TerminatedNot Applicable

Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)

Stopped: Slow recruitment, advances in technology

France314 participantsStarted 2018-07-09

Plain-language summary

This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy. The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention. The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).

Who can participate

Age range

18 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.

Pre-inclusion criteria: * Major patient with a colonoscopy scheduled in one of the participating hospitals (CHD Vendée and CHU Nantes). * Patient who agreed to participate in the study and gave his express consent * Patient affiliated with a social security system or beneficiary of a scheme Inclusion Criteria: * Patient with 1 or more polyps less than 20 mm observed during colonoscopy Exclusion Criteria: * Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms * Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis * Patient with familial adenomatous polyposis * Pregnant or lactating woman * Minor patient * Major patient under tutorship, curatorship, or deprived of liberty * Patient unable to understand protocol and / or give express consent * Patient not affiliated with a social security system or beneficiary of such a scheme * Patient hospitalized or treated without their consent

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

Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)

Timeframe: An average of 1 month

Trial details

NCT IDNCT03448653

SponsorCentre Hospitalier Departemental Vendee

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-12

Results submitted2024-07-10

View on ClinicalTrials.gov More Polyps of Colon trials