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NCT05687318 Clinical Trial

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

Artificial Intelligence Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05687318
Other study ID # PekingUMCH-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2022
Est. completion date August 2, 2023

Study information
Verified date December 2022
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 337
Est. completion date August 2, 2023
Est. primary completion date April 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• DeFrame
DeFrame can analyze colonoscopy medical images generated by electronic digestive endoscopy equipment to automatically identify, label and screen capture polyps in the colon.

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (3)
Lead Sponsor Collaborator
Peking Union Medical College Hospital The Loudi Central Hospital, the Second Affiliated Hospital of South China University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PMR Polyp miss rate during colonoscopy procedure
Secondary AMR Adenoma miss rate during colonoscopy procedure
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