Multispectral Imaging Endoscopy in Digestive Inflammation

NCT04287569 | Completed

• 2 other identifiers: P160409J2019-A01602-55
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Digestive Inflammation

Keywords

digestive inflammation; multispectral imaging; multispectral gastroscopy; multispectral coloscopy

Outcome Measures

Primary Outcomes (1)

• Reflectance endoscopy for gastric mucosa with lesions

  The reflectance endoscopy for gastric and rectal mucosa in different wavelength of presence of the lesions, in comparison with anatomopathological analysis on gastric and rectal mucosa, to diagnosis acute and chronic inflammation, glandular atrophy and intestinal metaplasia. This outcome will show reflectance for mucosa in presence of lesions which classified by anatomopathological analysis: comparison report.

  Up to 12 months

Secondary Outcomes (3)

• Statistic association between profiles of reflectance and anatomopathological classifications

  Up to 12 months

• Correlation between reflectance and intensity of inflammation

  Up to 12 months

• Sub-study: morphological comparison between 2D/3D reconstruction and endoscopist's description

  Up to 12 months

Study Arms (1)

video recording of endoscopy

EXPERIMENTAL

Record of sequences of video-endoscopy and the reflectance of light through fibroscopy

Device: Record during endoscopy of video-endoscopy sequences and reflectance

Interventions

Record during endoscopy of video-endoscopy sequences and reflectance DEVICE

Record of video-endoscopy sequences and reflectance, during endoscopy with biopsy.

video recording of endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service Hépato-Gastroentérologie, Hôpital Ambroise Paré

Boulogne-Billancourt, Île-de-France Region, 92100, France

Location

Study Officials

• Dominique Lamarque, MD, PhD

  Service Hépato-Gastroentérologie, Hôpital Ambroise Paré, Boulogne Billancourt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: February 27, 2020
• Study Start: September 2, 2020
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: August 28, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)