Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies (COLODETECT)

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

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)

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenoma Colon; Colonic Adenocarcinoma; Colorectal Polyp

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 34000
      • CHU Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria :

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

Exclusion Criteria :

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Colonoscopy Only Group
Artificial intelligence GI GENIUS ™ only Group
Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenomas Rate according to their morphology	according to Paris classification	4 months
Adenomas Rate according to their size	< 0,5mm / 0-5-10mm / > 10mm	4 months
Adenomas Rate according to their histology	according to Vienne classification	4 months
Caecal Intubation Rate	Complete colonocopy rate	4 months
Withdrawal time		4 months
Adverse effects	Haemorrhages, Perforation	4 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 2, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 21.06.06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No