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

Not Applicable

Completed

• Conditions: Enteroscope; Intestinal Polyposis, Adenomatous; Artificial Intelligence
• Interventions: Device: DeFrame

• Registration Number: NCT05687318
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-20
• Status Verified: 2022-12
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-18
• Primary Completion: 2023-04-28
• Study Completion: 2023-08-02
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Trial Ⅰ	DeFrame	Subjects underwent colonoscopy with the investigator's combined instrument, and then underwent traditional colonoscopy with the same investigator
Trial Ⅱ	DeFrame	Subjects underwent a traditional colonoscopy, followed by a colonoscopy with the same investigator's instrument

Primary Outcome Measures

Name	Time	Method
PMR	during colonoscopy procedure	Polyp miss rate

Secondary Outcome Measures

Name	Time	Method
AMR	during colonoscopy procedure	Adenoma miss rate

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China