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

NCT05481632 | Completed

• 1 other identifier: EndoAngel -CTP-01
• Study Type: interventional
• Target: 1,360
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Polyps

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Polyp detection rate

  3 months

Study Arms (2)

Physician AI-assisted diagnosis group

EXPERIMENTAL

Other: Endoangel assisted the process of colonoscopy

Physician Independent Diagnostic Group

SHAM COMPARATOR

Other: Colonoscopy was performed without endoangel assistance

Interventions

Endoangel assisted the process of colonoscopy OTHER

Endoangel assisted doctors to detect polyps

Physician AI-assisted diagnosis group

Colonoscopy was performed without endoangel assistance OTHER

Polyps were detected without ENDOANGEL assistance

Physician Independent Diagnostic Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Peking University Cancer Hospital & Institute: collaborator
• Wuhan Central Hospital: collaborator

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Intestinal Polyps

Condition Hierarchy (Ancestors)

Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 1, 2022
• Study Start: January 17, 2021
• Primary Completion: July 16, 2021
• Study Completion: March 4, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

CN (1)