Colorectal CancerNCT05237310
Comparing Detection of Standard Colonoscopy, CAD-EYE and Combined CAD-EYE and G-EYE® Aided Colonoscopy
A study testing Standard Colonoscopy, G-EYE Colonoscopy and CAD-EYE in people with Colorectal Cancer and Adenoma, run by Smart Medical Systems Ltd. at 1 site in Germany.
Trial summary
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Adenoma
- What is being tested?
- Standard Colonoscopy, G-EYE Colonoscopy and CAD-EYE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteGermany
- Study dates
- 2 Feb 2022to Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening and surveillance population for Adenoma and CRC.
- Subjects age is at least 18 years
- The patient must understand and sign a written informed consent for the procedure.
Who cannot join
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of hereditary polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with prior colonic surgery (exclusion appendectomy)
- Subjects with a history of radiation therapy to abdomen or pelvis;
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- Pregnant or lactating female subjects;
- Subjects who are currently enrolled in another clinical investigation.
- Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- Any patient condition deemed too risky for the study by the investigator
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
Wiesbaden, 65199
Ralf Kiesslich, Prof., +49 611 43-9002, Ralf.Kiesslich@helios-gesundheit.de
About this study
Official title: Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence (CAD-EYE) and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.
Read the detailed description
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria
- Conditions
- Colorectal Cancer, Adenoma
- Being tested
- Standard Colonoscopy, G-EYE Colonoscopy, CAD-EYE
- Keywords
- G-EYE, Colonoscopy, CAD-EYE, Adenoma, Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ColonoscopyDevice
Standard Colonoscopy using a standard Fujifilm colonoscope
G-EYE ColonoscopyDevice
G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope
CAD-EYEDevice
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence
| Study group | Role | What they receive |
|---|---|---|
| Standard Colonoscopy followed by CAD-EYE | Active comparator | Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Receives: Device: Standard Colonoscopy; Device: CAD-EYE |
| CAD-EYE followed by Standard Colonoscopy | Active comparator | Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Receives: Device: Standard Colonoscopy; Device: CAD-EYE |
| Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy | Active comparator | Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Receives: Device: Standard Colonoscopy; Device: G-EYE Colonoscopy; Device: CAD-EYE |
| Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy | Active comparator | Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Receives: Device: Standard Colonoscopy; Device: G-EYE Colonoscopy; Device: CAD-EYE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional Adenoma Detection
Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy
Measured: Upon histology results (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start2 Feb 2022
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2: Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B2: Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fujifilm
- Responsible party
- Sponsor
- Investigators
- Ralf Kiesslich, Prof., Principal investigator, Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237310
- Sponsor's protocol ID
- G-EYE 15076
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Tandem Study Comparing the Adenoma Detection and Miss-rate of Standard Colonoscopy to That of Artificial Intelligence (CAD-EYE) and to That of Artificial Intelligence (CAD-EYE) and G-EYE® Aided Colonoscopy
- ClinicalTrials.gov ID
- NCT05237310
- Acronym / sponsor ID
- G-EYE 15076
- Conditions
- Colorectal Cancer, Adenoma
- Keywords
- G-EYE, Colonoscopy, CAD-EYE, Adenoma, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fujifilm
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Feb 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.
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy.
Detailed description
The purpose of this study is to compare the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE® aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a single-center, four-arm dual-tandem, randomized, open-label study intended to compare the additional detection yield beyond standard colonoscopy obtained by performing combined CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2: Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B2: Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
| Arm | Type | Receives |
|---|---|---|
| Standard Colonoscopy followed by CAD-EYE | Active comparator | Device: Standard Colonoscopy, Device: CAD-EYESubjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
| CAD-EYE followed by Standard Colonoscopy | Active comparator | Device: Standard Colonoscopy, Device: CAD-EYESubjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
| Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy | Active comparator | Device: Standard Colonoscopy, Device: G-EYE Colonoscopy, Device: CAD-EYESubjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
| Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy | Active comparator | Device: Standard Colonoscopy, Device: G-EYE Colonoscopy, Device: CAD-EYESubjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Screening and surveillance population for Adenoma and CRC.
- Subjects age is at least 18 years
- The patient must understand and sign a written informed consent for the procedure.
Key exclusion criteria (11 listed)
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of hereditary polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with prior colonic surgery (exclusion appendectomy)
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 |
|---|---|---|
| Standard ColonoscopyStandard Colonoscopy using a standard Fujifilm colonoscope | Device | CAD-EYE followed by Standard Colonoscopy, Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy, Standard Colonoscopy followed by CAD-EYE, Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy |
| G-EYE ColonoscopyG-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope | Device | Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy, Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy |
| CAD-EYEColonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence | Device | CAD-EYE followed by Standard Colonoscopy, Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy, Standard Colonoscopy followed by CAD-EYE, Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy |
Primary outcome
Additional Adenoma Detection
Time frame: Upon histology results (up to 30 days)
Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Ralf Kiesslich, Prof. principal investigator
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Colonoscopy, G-EYE Colonoscopy and CAD-EYE in people with Colorectal Cancer and Adenoma, run by Smart Medical Systems Ltd. at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralf Kiesslich, Prof. (+49 611 43-9002, Ralf.Kiesslich@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Additional Adenoma Detection (time frame: Upon histology results (up to 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2022.