Viewing Study NCT05080088



Ignite Creation Date: 2024-05-06 @ 4:47 PM
Last Modification Date: 2024-10-26 @ 2:15 PM
Study NCT ID: NCT05080088
Status: COMPLETED
Last Update Posted: 2021-10-15
First Post: 2021-10-02

Brief Title: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies
Sponsor: Centre Hospitalier Universitaire de Nīmes
Organization: Centre Hospitalier Universitaire de Nīmes

Study Overview

Official Title: A Pilot Study Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS System the Artificial Intelligence GI GENIUS Alone and Colonoscopy Alone
Status: COMPLETED
Status Verified Date: 2021-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: COLODETECT
Brief Summary: Retrospective study single blind patient allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm

Colonoscopy Only Group
Artificial intelligence only group IA GI GENIUS alone
Endoscopic Cap and Artificial Intelligence Group endoscopy cap associated with the GI GENIUS IA System
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None