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

July 20, 2022 updated by: The Second Affiliated Hospital of Chongqing Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physician AI-assisted diagnosis group
Other: The reading process is assisted by ENDOANGEL
Diagnosis of benign and malignant lesions with the help of ENDOANGEL
Sham Comparator: Physician Independent Diagnostic Group
Other: No ENDOANGEL assistance during the reading process
Diagnosis of benign and malignant lesions without the help of ENDOANGEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AFROC-AUC
Time Frame: 3 months
AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer identification Sensitivity
Time Frame: 3 months
The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
3 months
Cancer identification specificity
Time Frame: 3 months
The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.
3 months
Cancer Identification Diagnosis Compliance Rate
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EndoAngel -CTP-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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