Efficacy of Artificial Intelligence-assisted Colonic Polyp Detection System
- Conditions
- Adenoma Colon
- Interventions
- Device: AI-assisted colonoscopy
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1906
Patients who need to undergo colonoscopy. -
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
- Arm && Interventions
Group Intervention Description AI-assisted group AI-assisted colonoscopy Subjects in this group undergo AI-assisted colonoscopy. The AI-assisted system not only has the function of automatic polyp detection, but also has the function of colonoscopy quality control.
- 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