Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

NCT05080088 | Completed

• 1 other identifier: 21.06.06
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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)

Conditions

Adenoma Colon; Colorectal Cancer; Colorectal Polyp; Colonic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software

  number of colonoscopies with the discovery of at least 1 colonic adenoma out of the total number of colonoscopies according to the use of colonoscopy alone / artificial intelligence alone / artificial intelligence combined with the endoscopic cap.

  4 months

Secondary Outcomes (6)

• Adenomas Rate according to their morphology

  4 months

• Adenomas Rate according to their size

  4 months

• Adenomas Rate according to their histology

  4 months

• Caecal Intubation Rate

  4 months

• Withdrawal time

  4 months

Study Arms (3)

Colonoscopy Only Group

Artificial intelligence GI GENIUS ™ only Group

Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients are recruited during a pre-colonoscopy consultation, carried out by the gastroenterologist in current practice

You may qualify if:

• years \< Patient \< 85 years
• Need to perform a primary and / or secondary screening colonoscopy for colorectal cancer
• Patients candidates for outpatient care

You may not qualify if:

• History of inflammatory digestive tract disease
• Failed previous colonoscopy
• Known familial polyposis
• Biopsy / polypectomy contraindication (coagulation disorder, treatment with CLOPIDOGREL / Anticoagulant)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nîmes

Nîmes, Gard, 34000, France

Location

Related Publications (1)

• Caillo L, Delliot C, Chevallier T, Bourgaux JF, Prost A, Brunaud-Gagniard B, Phoutthasang V, Clerc C, Borderie T, Daniel J, Pouderoux P, Debourdeau A. COLODETECT 1: comparative evaluation of endocuff with computer-aided detection versus computer-aided detection alone versus standard colonoscopy for enhancing adenoma detection rates during screening colonoscopy-a pilot study. Therap Adv Gastroenterol. 2024 Oct 27;17:17562848241290433. doi: 10.1177/17562848241290433. eCollection 2024.

  PMID: 39493261 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical student

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 15, 2021
• Study Start: April 6, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 8, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

FR (1)