Colonic PolypNCT04723758
COLO-DETECT: Can an Artificial Intelligence Device Increase Detection of Polyps During Colonoscopy?
A study testing GI Genius-assisted diagnostic colonoscopy and Diagnostic Colonoscopy in people with Colonic Polyp and Colorectal Polyp, run by South Tyneside and Sunderland NHS Foundation Trust at 10 sites in United Kingdom.
Trial summary
COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp, Colorectal Polyp, Colorectal Adenoma
- What is being tested?
- GI Genius-assisted diagnostic colonoscopy and Diagnostic Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,032 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 29 Mar 2021to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- Patients attending for colonoscopy
- Through standard National Health Service (NHS) care (most commonly due to iron deficiency anaemia, altered bowel habit, weight loss, rectal bleeding, positive FIT (faecal immunohistochemical test) based on symptoms, those referred on basis of family history, abnormal cross- sectional imaging, polyp surveillance or post CRC surveillance)
- Through Bowel Cancer Screening Programme (FIT positive, surveillance)
- Colonoscopy to be performed by colonoscopist trained to perform GGC as part of the study
Who cannot join
- Absolute contraindications to colonoscopy
- Patients lacking capacity to give informed consent
- Confirmed or expected pregnancy
- Established or suspected large bowel obstruction or pseudo-obstruction
- Known presence of colorectal cancer or polyposis syndromes
- Known colonic strictures (meaning that the colonoscopy maybe incomplete)
Show all 11Show fewer
- Known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
- Inflammatory Bowel Disease (IBD) surveillance procedures
- Patients who are on clopidogrel, warfarin, or other antiplatelet agents or anticoagulants who have not stopped this for the procedure (as polyps cannot be removed and thus histology cannot be confirmed)
- Patients who are attending for a planned therapeutic procedure or assessment of a known lesion
- Patients referred with polyps identified on Bowel Scope procedure
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Bolton NHS Foundation Trust
Bolton, BL4 0JR
North Tees and Hartlepool NHS Foundation Trust
Hartlepool, County Durham, TS24 9AH
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, Cumbria, LA9 7RG
Kettering General Hospital NHS Foundation Trust
Kettering, Northamptonshire, NN16 8UZ
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Teesside
The Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle upon Tyne, Tyne & Wear, NE7 7DN
Northumbria Healthcare NHS Foundation Trust
North Shields, North Tyneside, NE29 8NH
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, Tyne and Wear, SR4 7TP
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
University Hospitals Sussex NHS Foundation Trust
Worthing, Sussex, BN11 2DH
About this study
Official title: COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform
COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.
Read the detailed description
Colorectal cancer is common, affecting 1 in 15 men and 1 in 18 women in the UK in their lifetime. Many colorectal cancers develop from polyps via the adenoma-carcinoma sequence: there is a pre-cancerous stage (adenoma) during which it is possible to remove the polyp and therefore prevent it from progressing to colorectal cancer. The gold standard tool for doing this is colonoscopy. However, colonoscopy does not pick up all polyps, particularly flat polyps.
Missed polyps can result in colorectal cancer, so it is imperative to detect and remove as many polyps as possible. Many different interventions have been introduced to improve polyp detection, the most recent of which is artificial intelligence devices. GI Genius is an artificial intelligence device which integrates with existing colonoscopy equipment and analyses the video feed from the colonoscope camera in real time. Any areas that may represent an abnormality are then highlighted (without any lag) within a green box, alerting the colonoscopist to its presence. The potential abnormality can then be assessed more closely by the colonoscopist to decide whether it needs to be removed or not.
COLO-DETECT is a 2-arm, prospective, randomised controlled trial to assess whether GI Genius is able to detect more polyps (specifically, adenomas) during colonoscopy than standard colonoscopy without GI Genius. The primary outcome will be the mean number of adenomas per procedure (MAP) and the key secondary outcome will be the proportion of colonoscopies in which one or more adenomas is detected (Adenoma Detection Rate - ADR). These are both important quality markers for colonoscopy; the study will be powered to detect a clinically meaningful difference in ADR, which will by default detect a meaningful difference in MAP as the sample size required for ADR is larger.
In addition to measuring the effect of GI Genius on polyp detection, COLO-DETECT will provide a health economics analysis concerning the use of GI Genius, perform long-term passive follow-up to examine for future outcomes related to colorectal polyps and colorectal cancer, and perform additional nested studies (subject to ethical approval) that examine the effect upon users (for example through a visual scanning study) and their experience of using the GI Genius.
- Conditions
- Colonic Polyp, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal SSA, Sessile Serrated Adenoma
- Being tested
- GI Genius-assisted diagnostic colonoscopy, Diagnostic Colonoscopy
- Keywords
- Diagnostic Colonoscopy, Artificial Intelligence, Computer-Aided Detection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Genius-assisted diagnostic colonoscopyDevice
Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.
Diagnostic ColonoscopyDiagnostic test
Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.
| Study group | Role | What they receive |
|---|---|---|
| GI Genius-assisted colonoscopy (GGC) | Experimental | In the GGC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure, except that at some point prior to commencing withdrawal of the colonoscope, a member of the endoscopy staff will turn on the GI Genius machine. This will remain operational from the time it is switched on until the end of the procedure. Receives: Device: GI Genius-assisted diagnostic colonoscopy |
| Standard Colonoscopy (SC) | Active comparator | In the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure. Receives: Diagnostic Test: Diagnostic Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)
The number of adenomas identified during each colonoscopy will be summed and divided by the total number of colonoscopies performed. MAP is usually expressed as a number to one decimal place (e.g. 1.2).
Measured: The number of adenomas detected in each procedure will be counted at 14 days post-procedure
Secondary outcomes (30)
Proportion of participants in whom at least one adenoma is detected at colonoscopy, as indicated by the Adenoma Detection Rate (ADR)
Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies to give the ADR. ADR is usually expressed as a percentage.
Measured: The presence or absence of any adenomas will be determined at 14 days post-procedure
Number of adenomas per participant detected at colonoscopy in the 'screening' participant population, as indicated by MAP for that participant population.
The number of adenomas identified during each colonoscopy within the 'screening' participant population will be summed and divided by the total number of colonoscopies in that participant population. The MAP for the 'screening' participant population within each study arm will be compared
Measured: The number of adenomas detected will be counted at 14 days post-procedure
Number of adenomas per participant detected at colonoscopy in the 'symptomatic' participant population, as indicated by MAP for that participant population
The number of adenomas identified during each colonoscopy within the 'symptomatic' participant population will be summed and divided by the total number of colonoscopies in that participant population to calculate MAP. The MAP for the 'symptomatic' participant population within each study arm will be compared
Measured: The number of adenomas detected will be counted at 14 days post-procedure
Proportion of participants in the 'screening' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population
Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'screening' participant population within each study arm will be compared
Measured: The presence or absence of any adenomas will be determined at 14 days post-procedure
Proportion of participants in the 'symptomatic' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population
Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'symptomatic' participant population within each study arm will be compared
Measured: The presence or absence of any adenomas will be determined at 14 days post-procedure
Number of polyps per participant detected at colonoscopy, as indicated by the Mean number of Polyps per Procedure (MPP)
The total number of polyps detected during each colonoscopy will be summed, and divided by the total number of colonoscopies, to calculate MPP. MPP is usually expressed as a number to one decimal place.
Measured: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
Number of polyps per participant detected at colonoscopy in the 'screening' participant population, as indicated by the Mean number of Polyps per Procedure (MPP)
The total number of polyps detected during colonoscopy for each participant within the 'screening' participant population. will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.
Measured: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
Number of polyps per participant detected at colonoscopy in the 'symptomatic' participant population,as indicated by the Mean number of Polyps per Procedure (MPP)
The total number of polyps detected during colonoscopy for each participant within the 'symptomatic' participant population will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.
Measured: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
Proportion of participants in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Whether or not at least one polyp is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more polyps is detected will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.
Measured: The presence or absence of at least one polyp will be determined at the end of the procedure
Proportion of participants in the 'screening' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.
Measured: The presence or absence of at least one polyp will be determined at the end of the procedure
Proportion of participants in the 'symptomatic' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.
Measured: The presence or absence of at least one polyp will be determined at the end of the procedure
Polyp characteristics and location
The location, size, and morphology of the polyps identified (and histology if retrieved) in each study arm will be compared. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Measured: Assessed over duration of colonoscopy procedure and at time of 14 day post-colonoscopy review (once histology is known)
Sessile Serrated Polyp (SSP) detection rate
The number of colonoscopies in each study arm in which one or more SSPs is identified, divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Measured: SSP Detection Rate will be calculated at the time of study completion, expected to be 18 months
Colorectal Cancer (CRC) detection rate
The number of CRCs detected in each study arm divided by the total number of colonoscopies in each arm. This will include polyps removed and later found to cancerous on histology and lesions felt to be cancerous at the time of colonoscopy. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Measured: CRC Detection Rate will be calculated at the time of study completion, expected to be 18 months
Advanced Adenoma (AA) detection rate
The number of AAs detected in each study arm divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Measured: AA Detection Rate will be calculated at the time of study completion, expected to be 18 months
Caecal Intubation Rate
Caecal intubation rate (the proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon) will be compared between the study arms to assess for non-inferiority
Measured: Caecal Intubation Rate will be calculated at the time of study completion, expected to be 18 months
Insertion time to caecum
Insertion time to caecum (time taken to reach the furthest point of the large bowel) will be compared between the study arms to assess for non-inferiority
Measured: Measured during colonoscopy within the study.
Total Procedure Time
Total time required to perform the colonoscopy will be compared between the study arms to assess for non-inferiority
Measured: Measured during colonoscopy within the study.
Total Withdrawal Time (in absence of polyps)
Total withdrawal time (time taken to remove the colonoscope from the furthest point of the colon) in the absence of any polyps will be compared between the study arms to assess for non-inferiority
Measured: Measured during colonoscopy within the study.
Colonoscopist-assessed patient comfort score
Colonoscopist-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority
Measured: Measured during colonoscopy within the study.
Nurse-assessed patient comfort score
Nurse-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority
Measured: Measured during colonoscopy within the study.
Patient-Reported Experience
A validated Patient-Reported Experience Measure (Newcastle ENDOPREM) will be used to compare patient experience of colonoscopy between study arms
Measured: Assessed one day after the procedure
Patient-Reported Health-Related Quality of Life
The EuroQoL EQ-5D-5L (validated quality of life questionnaire) will be used to compare patient-reported health-related quality of life, between study arms
Measured: Assessed one day after the procedure
Projected future endoscopy workload
The need for further colonoscopy for each participant is determined by the findings at the index colonoscopy, according to national guidelines on polyp surveillance. This may differ between study arms if more polyps are identified in one arm.
Measured: Assessed immediately after colonoscopy
MAP according to BCSP status of colonoscopist
Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. MAP will be analysed by colonoscopist status within each study arm.
Measured: At the time of 14-day review
ADR according to BCSP status of colonoscopist
Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. ADR will be analysed by colonoscopist status within each study arm.
Measured: At the time of 14-day review
Change in number of adenomas detected per colonoscopy, for each colonoscopist, over the course of the study, as indicated by MAP
MAP for the first 20 percent of participants will be compared to MAP for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.
Measured: At the time of 14-day review
Change in proportion of participants in whom at least one adenoma is detected during colonoscopy, for each colonoscopist, over the course of the study, as indicated by ADR.
ADR for the first 20 percent of participants will be compared to ADR for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.
Measured: At the time of 14-day review
Change in number of adenomas detected per participant, for each participating colonoscopist, from pre-study to intra-study (SC arm only)
MAP may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.
Measured: At the time of 14-day review
Proportion of participants in whom at least one adenoma is detected during colonoscopy, for each participating colonoscopist, from pre-study to intra-study (SC arm only)
ADR may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.
Measured: At the time of 14-day review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start29 Mar 2021
- Primary completion6 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- North Wales Organisation for Randomised Trials in Health, Newcastle University, Medtronic
- Responsible party
- Sponsor
- Investigators
- Colin J Rees, MBBS, Study director, Newcastle University, South Tyneside and Sunderland NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723758
- Sponsor's protocol ID
- COLO-DETECT
- Other IDs
- 286426, 21-WS-003, 10451355
- Status last verified
- Nov 2023
- First submitted
- 5 Jan 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seager A, Sharp L, Neilson LJ, Brand A, Hampton JS, Lee TJW, Evans R, Vale L, Whelpton J, Bestwick N, Rees CJ; COLO-DETECT trial team. Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):911-923. doi: 10.1016/S2468-1253(24)00161-4. Epub 2024 Aug 14.
PubMed 39153491Seager A, Sharp L, Hampton JS, Neilson LJ, Lee TJW, Brand A, Evans R, Vale L, Whelpton J, Rees CJ. Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius artificial intelligence endoscopy module with standard colonoscopy. Colorectal Dis. 2022 Oct;24(10):1227-1237. doi: 10.1111/codi.16219. Epub 2022 Jun 28.
PubMed 35680613
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLO-DETECT: A Randomised Controlled Trial of Lesion Detection at Colonoscopy Using the GI Genius Artificial Intelligence Platform
- ClinicalTrials.gov ID
- NCT04723758
- Acronym / sponsor ID
- COLO-DETECT
- Conditions
- Colonic Polyp, Colorectal Polyp, Colorectal Adenoma, Colorectal Adenomatous Polyp, Colorectal SSA, Sessile Serrated Adenoma
- Keywords
- Diagnostic Colonoscopy, Artificial Intelligence, Computer-Aided Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,032 participants (actual)
- Lead sponsor
- South Tyneside and Sunderland NHS Foundation TrustUniversity, hospital or other
- Collaborators
- North Wales Organisation for Randomised Trials in Health, Newcastle University, Medtronic
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
COLO-DETECT is a clinical trial to evaluate whether an Artificial Intelligence device ("GI Genius", manufactured by Medtronic) can identify more polyps (pre-cancerous growths of the bowel lining) during colonoscopy (large bowel camera test) than during colonoscopy without it.
Detailed description
Colorectal cancer is common, affecting 1 in 15 men and 1 in 18 women in the UK in their lifetime. Many colorectal cancers develop from polyps via the adenoma-carcinoma sequence: there is a pre-cancerous stage (adenoma) during which it is possible to remove the polyp and therefore prevent it from progressing to colorectal cancer. The gold standard tool for doing this is colonoscopy. However, colonoscopy does not pick up all polyps, particularly flat polyps.
Missed polyps can result in colorectal cancer, so it is imperative to detect and remove as many polyps as possible. Many different interventions have been introduced to improve polyp detection, the most recent of which is artificial intelligence devices. GI Genius is an artificial intelligence device which integrates with existing colonoscopy equipment and analyses the video feed from the colonoscope camera in real time. Any areas that may represent an abnormality are then highlighted (without any lag) within a green box, alerting the colonoscopist to its presence. The potential abnormality can then be assessed more closely by the colonoscopist to decide whether it needs to be removed or not.
COLO-DETECT is a 2-arm, prospective, randomised controlled trial to assess whether GI Genius is able to detect more polyps (specifically, adenomas) during colonoscopy than standard colonoscopy without GI Genius. The primary outcome will be the mean number of adenomas per procedure (MAP) and the key secondary outcome will be the proportion of colonoscopies in which one or more adenomas is detected (Adenoma Detection Rate - ADR). These are both important quality markers for colonoscopy; the study will be powered to detect a clinically meaningful difference in ADR, which will by default detect a meaningful difference in MAP as the sample size required for ADR is larger.
In addition to measuring the effect of GI Genius on polyp detection, COLO-DETECT will provide a health economics analysis concerning the use of GI Genius, perform long-term passive follow-up to examine for future outcomes related to colorectal polyps and colorectal cancer, and perform additional nested studies (subject to ethical approval) that examine the effect upon users (for example through a visual scanning study) and their experience of using the GI Genius.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GI Genius-assisted colonoscopy (GGC) | Experimental | Device: GI Genius-assisted diagnostic colonoscopyIn the GGC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure, except that at some point prior to commencing withdrawal of the colonoscope, a member of the endoscopy staff will turn on the GI Genius machine. This will remain operational from the time it is switched on until the end of the procedure. |
| Standard Colonoscopy (SC) | Active comparator | Diagnostic Test: Diagnostic ColonoscopyIn the SC arm, participants will undergo colonoscopy as per standard care for the unit where they are having their procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to give informed consent
- Patients attending for colonoscopy
- Colonoscopy to be performed by colonoscopist trained to perform GGC as part of the study
Key exclusion criteria (11 listed)
- Absolute contraindications to colonoscopy
- Patients lacking capacity to give informed consent
- Confirmed or expected pregnancy
- Established or suspected large bowel obstruction or pseudo-obstruction
- Known presence of colorectal cancer or polyposis syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI Genius-assisted diagnostic colonoscopyParticipants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure. | Device | GI Genius-assisted colonoscopy (GGC) |
| Diagnostic ColonoscopyDiagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure. | Diagnostic test | Standard Colonoscopy (SC) |
Primary outcome
Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP)
Time frame: The number of adenomas detected in each procedure will be counted at 14 days post-procedure
The number of adenomas identified during each colonoscopy will be summed and divided by the total number of colonoscopies performed. MAP is usually expressed as a number to one decimal place (e.g. 1.2).
30 secondary outcomes
Proportion of participants in whom at least one adenoma is detected at colonoscopy, as indicated by the Adenoma Detection Rate (ADR)
Time frame: The presence or absence of any adenomas will be determined at 14 days post-procedure
Number of adenomas per participant detected at colonoscopy in the 'screening' participant population, as indicated by MAP for that participant population.
Time frame: The number of adenomas detected will be counted at 14 days post-procedure
Number of adenomas per participant detected at colonoscopy in the 'symptomatic' participant population, as indicated by MAP for that participant population
Time frame: The number of adenomas detected will be counted at 14 days post-procedure
Proportion of participants in the 'screening' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population
Time frame: The presence or absence of any adenomas will be determined at 14 days post-procedure
Proportion of participants in the 'symptomatic' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population
Time frame: The presence or absence of any adenomas will be determined at 14 days post-procedure
Number of polyps per participant detected at colonoscopy, as indicated by the Mean number of Polyps per Procedure (MPP)
Time frame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
Number of polyps per participant detected at colonoscopy in the 'screening' participant population, as indicated by the Mean number of Polyps per Procedure (MPP)
Time frame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
Number of polyps per participant detected at colonoscopy in the 'symptomatic' participant population,as indicated by the Mean number of Polyps per Procedure (MPP)
Time frame: Total number of polyps detected at colonoscopy will be determined at the end of the procedure
Proportion of participants in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Time frame: The presence or absence of at least one polyp will be determined at the end of the procedure
Proportion of participants in the 'screening' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Time frame: The presence or absence of at least one polyp will be determined at the end of the procedure
Proportion of participants in the 'symptomatic' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Time frame: The presence or absence of at least one polyp will be determined at the end of the procedure
Polyp characteristics and location
Time frame: Assessed over duration of colonoscopy procedure and at time of 14 day post-colonoscopy review (once histology is known)
Sessile Serrated Polyp (SSP) detection rate
Time frame: SSP Detection Rate will be calculated at the time of study completion, expected to be 18 months
Colorectal Cancer (CRC) detection rate
Time frame: CRC Detection Rate will be calculated at the time of study completion, expected to be 18 months
Advanced Adenoma (AA) detection rate
Time frame: AA Detection Rate will be calculated at the time of study completion, expected to be 18 months
Caecal Intubation Rate
Time frame: Caecal Intubation Rate will be calculated at the time of study completion, expected to be 18 months
Insertion time to caecum
Time frame: Measured during colonoscopy within the study.
Total Procedure Time
Time frame: Measured during colonoscopy within the study.
Total Withdrawal Time (in absence of polyps)
Time frame: Measured during colonoscopy within the study.
Colonoscopist-assessed patient comfort score
Time frame: Measured during colonoscopy within the study.
Nurse-assessed patient comfort score
Time frame: Measured during colonoscopy within the study.
Patient-Reported Experience
Time frame: Assessed one day after the procedure
Patient-Reported Health-Related Quality of Life
Time frame: Assessed one day after the procedure
Projected future endoscopy workload
Time frame: Assessed immediately after colonoscopy
MAP according to BCSP status of colonoscopist
Time frame: At the time of 14-day review
ADR according to BCSP status of colonoscopist
Time frame: At the time of 14-day review
Change in number of adenomas detected per colonoscopy, for each colonoscopist, over the course of the study, as indicated by MAP
Time frame: At the time of 14-day review
Change in proportion of participants in whom at least one adenoma is detected during colonoscopy, for each colonoscopist, over the course of the study, as indicated by ADR.
Time frame: At the time of 14-day review
Change in number of adenomas detected per participant, for each participating colonoscopist, from pre-study to intra-study (SC arm only)
Time frame: At the time of 14-day review
Proportion of participants in whom at least one adenoma is detected during colonoscopy, for each participating colonoscopist, from pre-study to intra-study (SC arm only)
Time frame: At the time of 14-day review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39153491Seager A, Sharp L, Neilson LJ, Brand A, Hampton JS, Lee TJW, Evans R, Vale L, Whelpton J, Bestwick N, Rees CJ; COLO-DETECT trial team. Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):911-923. doi: 10.1016/S2468-1253(24)00161-4. Epub 2024 Aug 14.
- Derived from this study: PubMed 35680613Seager A, Sharp L, Hampton JS, Neilson LJ, Lee TJW, Brand A, Evans R, Vale L, Whelpton J, Rees CJ. Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius artificial intelligence endoscopy module with standard colonoscopy. Colorectal Dis. 2022 Oct;24(10):1227-1237. doi: 10.1111/codi.16219. Epub 2022 Jun 28.
- Individual participant dataSharing planned: No
Related trials for Colonic Polyp
RecruitingObservational study
A Prospective Registry of Patients With Endoscopically Resected Malignant Colorectal Polyps (pT1 Colorectal Cancer)
Malignant Colorectal Polyp, Colorectal Cancer
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
Enrolling by invitation
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Colon Polyp, Adenoma
RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
Recruiting
Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)
Colorectal Cancer, Colorectal Polyp
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin J Rees, MBBS study director
Newcastle University, South Tyneside and Sunderland NHS Foundation Trust
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GI Genius-assisted diagnostic colonoscopy and Diagnostic Colonoscopy in people with Colonic Polyp and Colorectal Polyp, run by South Tyneside and Sunderland NHS Foundation Trust at 10 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adenomas per participant detected at colonoscopy as indicated by the Mean Number of Adenomas per Procedure (MAP) (time frame: The number of adenomas detected in each procedure will be counted at 14 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04723758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.