Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System

Adenoma Colon Clinical Trial

Official title:

Research on the Auxiliary Diagnosis and Treatment System of Digestive Endoscopy Based on Artificial Intelligence: An Efficacy Study of Artificial Intelligence-assisted Colonic Polyp Detection System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05941689
• Other study ID #: 202306499
• Status: Completed
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1906
• Est. completion date: September 30, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Polyps

Intervention

Device:
• AI-assisted colonoscopy
AI can not only detect suspicious lesions timely, and label them in the field of view of the colonoscopy, but also monitor withdrawal speed and calculate the clean withdrawal time automatically.

Locations

Country	Name	City	State
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Loudi Central Hospital	Loudi	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adenoma detection rate	The proportion of patients with at least one histologically proven adenoma or carcinoma	up to 2months
Primary	withdrawal time compliance rate	The proportion of patients with clean withdrawal time >6min.	up to 2months
Secondary	polyp detection rate	The proportion of patients with at least one polyp.	up to 2 months
Secondary	adenoma per colonoscopy	The number of adenomas detected per colonoscopy	up to 2 months
Secondary	polyp per colonoscopy	The number of polys detected per colonoscopy	up to 2 months