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NCT05687318
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
Conditions: Artificial Intelligence, Enteroscope, Intestinal Polyposis, Adenomatous
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 354
Sponsor: Peking Union Medical College Hospital
Location: China
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.
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.
Source: ClinicalTrials.gov (NCT05687318). StuddyBuddy aggregates publicly available trial information.