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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The reading process is assisted by ENDOANGEL
No ENDOANGEL assistance during the reading process
Sponsored by
The Second Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥18, male or female；
  2. Cases with complete, clear imaging data, including images under white light and magnified stained images；
  3. Complete pathological diagnosis of upper digestive tract lesions;
  4. The included cases were excluded from the software development.

Exclusion Criteria:

  1. Cases whose image data did not meet the evaluation requirements;
  2. The investigator considered the case unsuitable for the clinical trial.

Sites / Locations

  • The Second Hospital of Chongqing Medical UniversityRecruiting

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

AFROC-AUC
AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.

Secondary Outcome Measures

Cancer identification Sensitivity
The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
Cancer identification specificity
The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.
Cancer Identification Diagnosis Compliance Rate
The numerator is the total number of true positives plus true negatives, and the denominator is the total number of true positives, false positives, true negatives, and false negatives.

Full Information

First Posted
July 20, 2022
Last Updated
July 20, 2022
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05470452
Brief Title
Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Official Title
Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University

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
The upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed by Wuhan ENDOANGEL Medical Technology Co., Ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. The aim of this study is to evaluate the safety and effectiveness of the software in clinical use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

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)
The reading process is assisted by ENDOANGEL
Intervention Description
Diagnosis of benign and malignant lesions with the help of ENDOANGEL
Intervention Type
Other
Intervention Name(s)
No ENDOANGEL assistance during the reading process
Intervention Description
Diagnosis of benign and malignant lesions without the help of ENDOANGEL
Primary Outcome Measure Information:
Title
AFROC-AUC
Description
AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cancer identification Sensitivity
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
Cancer identification specificity
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
Title
Cancer Identification Diagnosis Compliance Rate
Description
The numerator is the total number of true positives plus true negatives, and the denominator is the total number of true positives, false positives, true negatives, and false negatives.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18, male or female； Cases with complete, clear imaging data, including images under white light and magnified stained images； Complete pathological diagnosis of upper digestive tract lesions; The included cases were excluded from the software development. Exclusion Criteria: Cases whose image data did not meet the evaluation requirements; The investigator considered the case unsuitable for the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Song He, MD
Phone
+8613808336120
Email
dengchao1990@hospital.cqmu.edu.cn
Facility Information:
Facility Name
The Second Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Deng
Phone
+8615123172616
Email
dengchao1990@hospital.cqmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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