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
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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COMPLETED
NA
337 participants
INTERVENTIONAL
2022-09-20
2023-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
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
DeFrame
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
DeFrame
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* (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.
18 Years
85 Years
ALL
Yes
Sponsors
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The Second Hospital University of South China
OTHER
Loudi Central Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PekingUMCH-1
Identifier Type: -
Identifier Source: org_study_id
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