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

NCT ID: NCT05687318

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2023-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Artificial Intelligence Enteroscope Intestinal Polyposis, Adenomatous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Trial Ⅰ

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

Group Type EXPERIMENTAL

DeFrame

Intervention Type 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 Ⅱ

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

Group Type EXPERIMENTAL

DeFrame

Intervention Type DEVICE

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

Interventions

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DeFrame

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Hospital University of South China

OTHER

Sponsor Role collaborator

Loudi Central Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PekingUMCH-1

Identifier Type: -

Identifier Source: org_study_id

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