Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy

Not Applicable

Completed

• Conditions: Adenoma Colon; Colonic Adenoma

• Registration Number: NCT05862948
• Lead Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-30
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Study First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate (ADR)	1 years	ADR defined as the proportion of patients with at least 1 adenoma detected.

Secondary Outcome Measures

Name	Time	Method
Polyp per colonoscopy (PPC)	1 years	PPC defined as total number of polyps resected divided by the total number of colonoscopies.
Adenoma per colonoscopy (APC)	1 years	APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Polyp detection rate (PDR)	1 years	PDR defined as the proportion of patients with at least 1 polyp detected.
Sessile serrated lesion detection rate (SSLDR)	1 years	SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies.
Advanced adenoma detection rate (AADR)	1 years	AADR Adenomas are classified as advanced with a size \>= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD)

Trial Locations

Locations (2)

Fondazione Poliambulanza; 🇮🇹 Brescia, Bs, Italy

Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, Italy