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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05481632
Other study ID # EndoAngel -CTP-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2021
Est. completion date March 4, 2022

Study information

Verified date July 2022
Source Ruijin Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1360
Est. completion date March 4, 2022
Est. primary completion date July 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Endoangel assisted the process of colonoscopy
Endoangel assisted doctors to detect polyps
Colonoscopy was performed without endoangel assistance
Polyps were detected without ENDOANGEL assistance

Locations

Country Name City State
China Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (3)

Lead Sponsor Collaborator
Ruijin Hospital Peking University Cancer Hospital & Institute, Wuhan Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity of polyps identification The numerator is the number of true positives and the denominator is the total number of true positives and false negatives. 3 months
Primary specificity of polyps identification The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives. 3 months
Secondary Polyp detection rate The numerator is subjects with polyps detected and the denominator is all subjects. 3 months
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