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

Primary Purpose

Intestinal Polyps

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoangel assisted the process of colonoscopy
Colonoscopy was performed without endoangel assistance
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intestinal Polyps

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Physician AI-assisted diagnosis group

Physician Independent Diagnostic Group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Polyp detection rate
The numerator is subjects with polyps detected and the denominator is all subjects.

Full Information

First Posted
July 22, 2022
Last Updated
July 28, 2022
Sponsor
Ruijin Hospital
Collaborators
Peking University Cancer Hospital & Institute, Wuhan Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05481632
Brief Title
Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Official Title
Validating the Safety and Effectiveness of ENDOANGEL Lower Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2021 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
Collaborators
Peking University Cancer Hospital & Institute, Wuhan Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Polyps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physician AI-assisted diagnosis group
Arm Type
Experimental
Arm Title
Physician Independent Diagnostic Group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Endoangel assisted the process of colonoscopy
Intervention Description
Endoangel assisted doctors to detect polyps
Intervention Type
Other
Intervention Name(s)
Colonoscopy was performed without endoangel assistance
Intervention Description
Polyps were detected without ENDOANGEL assistance
Primary Outcome Measure Information:
Title
sensitivity of polyps identification
Description
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
Title
specificity of polyps identification
Description
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 Outcome Measure Information:
Title
Polyp detection rate
Description
The numerator is subjects with polyps detected and the denominator is all subjects.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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