COLODETECT: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Completed

CT.gov ID

NCT05080088

Collaborator

(none)

Enrollment

Location

3.1

Actual Duration (Months)

29.5

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Adenoma Colon Colorectal Cancer Colorectal Polyp Colonic Adenocarcinoma

Study Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Apr 6, 2021

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Colonoscopy Only Group
Artificial intelligence GI GENIUS ™ only Group
Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group

Outcome Measures

Primary Outcome Measures

Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software [4 months]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Nîmes	Nîmes	Gard	France	34000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clément Delliot, medical student, Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT05080088

Other Study ID Numbers:

21.06.06

First Posted:

Oct 15, 2021

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenoma

Study Results

No Results Posted as of Oct 15, 2021