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 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

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.

Study Overview

• Status: Completed
• Conditions: Artificial Intelligence; Enteroscope; Intestinal Polyposis, Adenomatous
• Intervention / Treatment: Device: DeFrame

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PMR	Polyp miss rate	during colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMR	Adenoma miss rate	during colonoscopy procedure

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: the Second Affiliated Hospital of South China University; The Loudi Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; Polyps; Adenomatous Polyps; Adenoma; Adenomatous Polyposis Coli; Intestinal Polyps; Intestinal Polyposis
• Other Study ID Numbers: PekingUMCH-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No