NCT05687318CompletedNot Applicable
A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment, a Prospective, Multicenter, Randomized Stratified Block, Incomplete Blind Setting, Parallel Sequential Control, and Efficacy Test
Peking Union Medical College Hospital1 site in 1 country337 target enrollmentStarted: September 20, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 337
- Locations
- 1
- Primary Endpoint
- PMR
Study Overview
Brief Summary
A clinical trial of the effectiveness and safety of intestinal polyp digestive endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images generated by electronic digestive endoscopy equipment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age of 18 to 85 years old, regardless of gender;
- •electronic colonoscopy is required;
- •The subjects or their legal representatives could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.
Exclusion Criteria
- •(1) Contraindications associated with electronic colonoscopy or biopsy;
- •(2) poor intestinal preparation;
- •(3) diagnosed colorectal cancer, familial polyposis, or complicated with known colorectal polyps;
- •(4) serious neurological diseases or dysfunction of vital organs (heart, lung, liver, kidney);
- •(5) acute abdominal or intestinal inflammation;
- •(6) History of abdominal, pelvic, anal and perianal operations within 2 months before enrollment;
- •(7) Participated in other interventional clinical trials within 1 month before enrollment;
- •(8) In the interest of subjects, the investigator considers that they should not participate in other conditions of the clinical trial.
Arms & Interventions
Trial Ⅰ
Experimental
Subjects underwent colonoscopy with the investigator's combined instrument, and then underwent traditional colonoscopy with the same investigator
Intervention: DeFrame (Device)
Trial Ⅱ
Experimental
Subjects underwent a traditional colonoscopy, followed by a colonoscopy with the same investigator's instrument
Intervention: DeFrame (Device)
Outcomes
Primary Outcomes
PMR
Time Frame: during colonoscopy procedure
Polyp miss rate
Secondary Outcomes
- AMR(during colonoscopy procedure)
Investigators
Study Sites (1)
Loading locations...
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