Polyp of ColonNCT05178095
Artificial Intelligence in Colonic Polyp Detection
A study testing Artificial intelligence and No Artificial Intelligence in people with Polyp of Colon and Adenoma Colon, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Polyp of Colon, Adenoma Colon, Gastrointestinal Neoplasms
- What is being tested?
- Artificial intelligence and No Artificial Intelligence
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2020to 1 Jun 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients without IBD referred for colonoscopy
Who cannot join
- Age < 40 years
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.
- Conditions
- Polyp of Colon, Adenoma Colon, Gastrointestinal Neoplasms
- Being tested
- Artificial intelligence, No Artificial Intelligence
- Keywords
- colonoscopy, artificial intelligence
- Medical subject headings
- Colonic Polyps, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligenceDevice
Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps
No Artificial IntelligenceDevice
Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps
| Study group | Role | What they receive |
|---|---|---|
| AI | Experimental | Colonoscopy with AI Receives: Device: Artificial intelligence |
| No AI | Placebo comparator | Colonoscopy without AI Receives: Device: No Artificial Intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADR
Adenoma detection rate
Measured: 1 hour
Secondary outcomes (2)
APC
Adenomas per colonoscopy
Measured: 1 hour
Procedural time
The number of minutes required to complete the colonoscopy withdrawal
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start30 Sep 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyp of ColonStudies 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
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hedenström, Sahlgrenska University Hospital
- Investigators
- Björn Lindkvist, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178095
- Sponsor's protocol ID
- Dnr 2020-01951
- Status last verified
- Jun 2023
- First submitted
- 15 Nov 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scholer J, Alavanja M, de Lange T, Yamamoto S, Hedenstrom P, Varkey J. Impact of AI-aided colonoscopy in clinical practice: a prospective randomised controlled trial. BMJ Open Gastroenterol. 2024 Jan 30;11(1):e001247. doi: 10.1136/bmjgast-2023-001247.
PubMed 38290758
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in Colonic Polyp Detection
- ClinicalTrials.gov ID
- NCT05178095
- Acronym / sponsor ID
- Dnr 2020-01951
- Conditions
- Polyp of Colon, Adenoma Colon, Gastrointestinal Neoplasms
- Keywords
- colonoscopy, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 5 Jan 2022 (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.
A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI | Experimental | Device: Artificial intelligenceColonoscopy with AI |
| No AI | Placebo comparator | Device: No Artificial IntelligenceColonoscopy without AI |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients without IBD referred for colonoscopy
Key exclusion criteria (2 listed)
- Age < 40 years
- Not willing to participate
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 |
|---|---|---|
| Artificial intelligenceColonoscopy with the aid of artificial intelligence for the detection of colonic polyps | Device | AI |
| No Artificial IntelligenceColonoscopy without the aid of artificial intelligence for the detection of colonic polyps | Device | No AI |
Primary outcome
ADR
Time frame: 1 hour
Adenoma detection rate
2 secondary outcomes
APC
Time frame: 1 hour
Procedural time
Time frame: 1 hour
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 Jun 2023.
- Derived from this study: PubMed 38290758Scholer J, Alavanja M, de Lange T, Yamamoto S, Hedenstrom P, Varkey J. Impact of AI-aided colonoscopy in clinical practice: a prospective randomised controlled trial. BMJ Open Gastroenterol. 2024 Jan 30;11(1):e001247. doi: 10.1136/bmjgast-2023-001247.
- Individual participant dataSharing planned: Undecided
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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.
Björn Lindkvist study director
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence and No Artificial Intelligence in people with Polyp of Colon and Adenoma Colon, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 2 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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. Some participants in this study may receive a placebo. 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?
ADR (time frame: 1 hour). 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 NCT05178095, which also lists 1 linked publication.
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 Jun 2023.