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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Artificial Intelligence, Enteroscope, Intestinal Polyposis, Adenomatous

Intervention / Treatment
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* Device: DeFrame


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Ⅰ<br>Subjects underwent colonoscopy with the investigator's combined instrument, and then underwent traditional colonoscopy with the same investigator | Device: DeFrame<br>* DeFrame can analyze colonoscopy medical images generated by electronic digestive endoscopy equipment to automatically identify, label and screen capture polyps in the colon.<br>|
| Experimental: Trial Ⅱ<br>Subjects underwent a traditional colonoscopy, followed by a colonoscopy with the same investigator's instrument | Device: DeFrame<br>* DeFrame can analyze colonoscopy medical images generated by electronic digestive endoscopy equipment to automatically identify, label and screen capture polyps in the colon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PMR | Polyp miss rate | during colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMR | Adenoma miss rate | during colonoscopy procedure |