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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05687318

Collaborator

(none)

354

Enrollment

Location

Arms

8.3

Anticipated Duration (Months)

42.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Artificial Intelligence Enteroscope Intestinal Polyposis, Adenomatous	Device: DeFrame	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

354 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Sep 20, 2022

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trial Ⅰ Subjects underwent colonoscopy with the investigator's combined instrument, and then underwent traditional colonoscopy with the same investigator	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.
Experimental: Trial Ⅱ Subjects underwent a traditional colonoscopy, followed by a colonoscopy with the same investigator's instrument	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.

Arm

Intervention/Treatment

Experimental: Trial Ⅰ

Subjects underwent colonoscopy with the investigator's combined instrument, and then underwent traditional colonoscopy with the same investigator

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.

Experimental: Trial Ⅱ

Subjects underwent a traditional colonoscopy, followed by a colonoscopy with the same investigator's instrument

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.

Outcome Measures

Primary Outcome Measures

PMR [during colonoscopy procedure]
Polyp miss rate

Secondary Outcome Measures

AMR [during colonoscopy procedure]
Adenoma miss rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05687318

Other Study ID Numbers:

PekingUMCH-1

First Posted:

Jan 18, 2023

Last Update Posted:

Jan 18, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenomatous Polyposis Coli

Intestinal Polyposis

Intestinal Polyps

Study Results

No Results Posted as of Jan 18, 2023