Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy (ACCENDO-Colo)

Fondazione Poliambulanza Istituto Ospedaliero

Status

Completed

Conditions

Colonic Adenoma

Adenoma Colon

Treatments

Device: ENDO-Aid by Olympus

Study type

Interventional

Funder types

Other

Identifiers

NCT05862948

NP4834

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.

Enrollment

1,160 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years or ≤85
Patients undergoing screening, follow-up, or diagnostic colonoscopy

Exclusion criteria

Suspected or known inflammatory bowel disease
Colonic resection
Taking anticoagulants or antiaggregants that contraindicate the performance of therapy
Patients with incomplete colonoscopy
Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate.
Inability to provide informed consent.