CompletedNot Applicable

Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting

Italy1,156 participantsStarted 2020-12-16

Plain-language summary

The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.

Who can participate

Age range

50 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 50 to 74 undergoing colonoscopy examination following a prior colonsocopy were polyps were found (follow-up) performed in the context of a regional mass-screening program. Exclusion Criteria: * Patients unwilling or unable to give informed consent. * Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adenoma detection rate

Timeframe: When available the histological report of polyps removed (up to 3 weeks).

Rate of patients detected with 3 or more adenomas.

Timeframe: When available the histological report of polyps removed (up to 3 weeks).

Trial details

NCT IDNCT06160466

SponsorFondazione Poliambulanza Istituto Ospedaliero

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Colonic Adenoma trials