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

Intestinal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481632
• Other study ID #: EndoAngel -CTP-01
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Intestinal Polyps

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