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Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05080088
Acronym
COLODETECT
Enrollment
90
Registered
2021-10-15
Start date
2021-04-06
Completion date
2021-07-08
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon, Colonic Adenocarcinoma, Colorectal Cancer, Colorectal Polyp

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)

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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)

Design outcomes

Primary

MeasureTime frameDescription
Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software4 monthsnumber 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

MeasureTime frameDescription
Adverse effects4 monthsHaemorrhages, Perforation
Adenomas Rate according to their morphology4 monthsaccording to Paris classification
Withdrawal time4 months
Adenomas Rate according to their histology4 monthsaccording to Vienne classification
Caecal Intubation Rate4 monthsComplete colonocopy rate
Adenomas Rate according to their size4 months\< 0,5mm / 0-5-10mm / \> 10mm

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026