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OpenTrials
Completed

NCT Number: NCT05481632

Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software

To evaluate the safety and effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed and manufactured by Wuhan ENDOANGEL Medical Technology Co., Ltd.

Completed

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years old ≤ age ≤ 75 years old, male or female;
  • Subjects with colonoscopy diagnosis and screening needs;
  • Sign the Written Informed Consent Form;
  • With full capacity for civil conduct.

Exclusion criteria

  • History of acute myocardial infarction (within 6 months), severe heart, liver, and renal insufficiency or mental disease;
  • Patients who are taking aspirin, warfarin, and other anticoagulants;
  • Patients with inflammatory bowel disease, or polyposis syndromes, or confirmed or highly suspected colon cancer;
  • History of colorectal surgery;
  • Patients with familial adenomatous polyposis;
  • Pregnant women (if the subject is a woman of reproductive age and cannot confirm whether she is pregnant, a pregnancy test is required);
  • Patients who are participating in clinical trials of other drugs or medical devices;
  • Patients who are not eligible to participate in this clinical trial in the opinion of the investigator.

Treatment and study plan

Endoangel assisted the process of colonoscopy

Other

Endoangel assisted doctors to detect polyps

Colonoscopy was performed without endoangel assistance

Other

Polyps were detected without ENDOANGEL assistance

Primary outcomes

  1. sensitivity of polyps identification

    Time frame: 3 months

    The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.

  2. specificity of polyps identification

    Time frame: 3 months

    The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.

Secondary outcomes

  1. Polyp detection rate

    Time frame: 3 months

    The numerator is subjects with polyps detected and the denominator is all subjects.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Peking University Cancer Hospital & Institute
  • Wuhan Central Hospital

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Aug 1, 2022

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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