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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Artificial Intelligence
• Intestinal Polyposis
• Intestinal Polyps

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