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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05481632

Enrollment

1360

Registered

2022-08-01

Start date

2021-01-17

Completion date

2022-03-04

Last updated

2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Polyps

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.

Interventions

OTHEREndoangel assisted the process of colonoscopy

Endoangel assisted doctors to detect polyps

OTHERColonoscopy was performed without endoangel assistance

Polyps were detected without ENDOANGEL assistance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
sensitivity of polyps identification	3 months	The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
specificity of polyps identification	3 months	The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.

Secondary

Measure	Time frame	Description
Polyp detection rate	3 months	The numerator is subjects with polyps detected and the denominator is all subjects.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026