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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

Primary Purpose

Artificial Intelligence, Enteroscope, Intestinal Polyposis, Adenomatous

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DeFrame
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Artificial Intelligence

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Trial Ⅰ

Trial Ⅱ

Arm Description

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

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

Outcomes

Primary Outcome Measures

PMR
Polyp miss rate

Secondary Outcome Measures

AMR
Adenoma miss rate

Full Information

First Posted
January 3, 2023
Last Updated
August 31, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
The Second Hospital University of South China, The Loudi Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05687318
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
The Second Hospital University of South China, The Loudi Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Intelligence, Enteroscope, Intestinal Polyposis, Adenomatous

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial Ⅰ
Arm Type
Experimental
Arm Description
Subjects underwent colonoscopy with the investigator's combined instrument, and then underwent traditional colonoscopy with the same investigator
Arm Title
Trial Ⅱ
Arm Type
Experimental
Arm Description
Subjects underwent a traditional colonoscopy, followed by a colonoscopy with the same investigator's instrument
Intervention Type
Device
Intervention Name(s)
DeFrame
Intervention Description
DeFrame can analyze colonoscopy medical images generated by electronic digestive endoscopy equipment to automatically identify, label and screen capture polyps in the colon.
Primary Outcome Measure Information:
Title
PMR
Description
Polyp miss rate
Time Frame
during colonoscopy procedure
Secondary Outcome Measure Information:
Title
AMR
Description
Adenoma miss rate
Time Frame
during colonoscopy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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

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