Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

Colorectal Cancer Clinical Trial

— COLODETECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080088
• Other study ID #: 21.06.06
• Status: Completed
• Start date: April 6, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 8, 2021
• Est. primary completion date: July 1, 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Adenocarcinoma
• Colorectal Cancer
• Colorectal Polyp

Locations

Country	Name	City	State
France	CHU Nîmes	Nîmes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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