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

NCT05687318 | Completed

• 1 other identifier: PekingUMCH-1
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

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.

Conditions

Artificial Intelligence; Enteroscope; Intestinal Polyposis, Adenomatous

Outcome Measures

Primary Outcomes (1)

• PMR

  Polyp miss rate

  during colonoscopy procedure

Secondary Outcomes (1)

• AMR

  during colonoscopy procedure

Study Arms (2)

Trial Ⅰ

EXPERIMENTAL

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

Device: DeFrame

Trial Ⅱ

EXPERIMENTAL

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

Device: DeFrame

Interventions

DeFrame DEVICE

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

Trial Ⅰ; Trial Ⅱ

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• The Second Hospital University of South China: collaborator
• Loudi Central Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 18, 2023
• Study Start: September 20, 2022
• Primary Completion: April 28, 2023
• Study Completion: August 2, 2023
• Last Updated: September 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)