Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System

Not Applicable

Completed

• Conditions: Adenoma Colon

• Registration Number: NCT05941689
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

This is a randomized controlled multicenter clinical trial of computer-aided detection (CADe) system for the adjuvant diagnosis of intestinal polyps/adenomas ever conducted in a Chinese population. In addition, this study will evaluate the effect of CADe system on adenoma detection of endoscopists under fatigue.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Study Start: 2023-07-25
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-30
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1906

Inclusion Criteria

Patients who need to undergo colonoscopy. -

Exclusion Criteria

Patients with CRC, inflammatory bowel disease, previous colonic resection, and antithrombotic therapy precluding polyp resection were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
adenoma detection rate	up to 2months	The proportion of patients with at least one histologically proven adenoma or carcinoma
withdrawal time compliance rate	up to 2months	The proportion of patients with clean withdrawal time \>6min.

Secondary Outcome Measures

Name	Time	Method
adenoma per colonoscopy	up to 2 months	The number of adenomas detected per colonoscopy
polyp per colonoscopy	up to 2 months	The number of polys detected per colonoscopy
polyp detection rate	up to 2 months	The proportion of patients with at least one polyp.

Trial Locations

Locations (2)

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China

Loudi Central Hospital; 🇨🇳 Loudi, Hunan, China