CompletedNot Applicable

Multispectral Imaging Endoscopy in Digestive Inflammation

France102 participantsStarted 2020-09-02

Plain-language summary

The study aims as principal objective to show the association between reflectance intensity of mucosa at different wave lengths and * the presence of acute or chronic inflammation in stomach or rectum and normal mucosa; * the presence of glandular atrophy in stomach or intestinal metaplasia. The secondary objectives are: * to identify reflectance profile which characterize an acute or a chronic inflammation, a glandular atrophy or an intestinal metaplasia, respectively; * to find a correlation between the reflectance to different frequencies and intensity of inflammation according to Sydney Classification in stomach (Dixon M F 1994) and in rectum (Erben U 2014).

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.

Inclusion Criteria: * Patients needing a digestive endoscopy under general anesthesia, or a rectoscopy without anesthesia, with indicators of systematic biopsy regardless of reason; * Aged ≥ 18 years; * Covered by a public health insurance regime; * Signed consent. Exclusion Criteria: * History of gastric or rectal surgery regardless of nature; * Gastrointestinal bleeding by hematemesis or rectal bleeding; * Hemostasis disorders preventing biopsy. * Difficulties in understanding french language; * Pregnant or breast feeding woman; * Woman of childbearing age without reliable contraception; * Adult under legal protection with tutor or curator.

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

Reflectance endoscopy for gastric mucosa with lesions

Timeframe: Up to 12 months

Trial details

NCT IDNCT04287569

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-22

View on ClinicalTrials.gov More Digestive Inflammation trials