CompletedNCT05481632Updated Aug 1, 2022

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

An interventional study of Endoangel assisted the process of colonoscopy and Colonoscopy was performed without endoangel assistance in Intestinal Polyps, sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-01.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

Registered 1 year 6 months after the study started (first participant enrolled Jan 2021, registered Jul 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 1,360
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Intestinal Polyps

In context

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts 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

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

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 1,360 participants (actual)

Study arms

Experimental
Physician AI-assisted diagnosis group
Other: Endoangel assisted the process of colonoscopy
Sham comparator
Physician Independent Diagnostic Group
Other: Colonoscopy was performed without endoangel assistance

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

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 3 months

Secondary outcomes

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

Study locations

1 site

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200000, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05481632
Lead sponsor: Ruijin Hospital
Collaborators: Peking University Cancer Hospital & Institute, Wuhan Central Hospital
Responsible party: Sponsor
First posted: Aug 1, 2022
Start date: Jan 17, 2021
Primary completion: Jul 16, 2021
Completion: Mar 4, 2022
Last update: Aug 1, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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