NCT05718193CompletedNot Applicable
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps
Xiangya Hospital of Central South University2 sites in 1 country2,868 target enrollmentStarted: June 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,868
- Locations
- 2
- Primary Endpoint
- adenoma detection rate
Study Overview
Brief Summary
To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.
Exclusion Criteria
- •History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.
Outcomes
Primary Outcomes
adenoma detection rate
Time Frame: up to 9 months
Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies.
adenomas per colonoscopy
Time Frame: up to 9 months
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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