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NCT Number: 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

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.

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Key information

Conditions

Artificial Intelligence Adenoma Adenomatous Polyposis Coli Adenomatous Polyps Colonic Diseases Colorectal Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Enteroscope Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Intestinal Polyposis Intestinal Polyposis, Adenomatous Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Syndromes, Hereditary

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DeFrame

Device

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

Primary outcomes

  1. PMR

    Time frame: during colonoscopy procedure

    Polyp miss rate

Secondary outcomes

  1. AMR

    Time frame: during colonoscopy procedure

    Adenoma miss rate

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Loudi Central Hospital
  • The Second Hospital University of South China

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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