Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies

NCT ID: NCT05080088

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-06

Study Completion Date

2021-07-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenoma Colon Colorectal Cancer Colorectal Polyp Colonic Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colonoscopy Only Group

No interventions assigned to this group

Artificial intelligence GI GENIUS ™ only Group

No interventions assigned to this group

Endoscopic Cap and Artificial Intelligence GI GENIUS ™ Group

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Clément Delliot

medical student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Nîmes

Nîmes, Gard, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39493261 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21.06.06

Identifier Type: -

Identifier Source: org_study_id