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

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Other: The reading process is assisted by ENDOANGEL; Other: No ENDOANGEL assistance during the reading process

• Registration Number: NCT05470452
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-28
• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physician AI-assisted diagnosis group	The reading process is assisted by ENDOANGEL	-
Physician Independent Diagnostic Group	No ENDOANGEL assistance during the reading process	-

Primary Outcome Measures

Name	Time	Method
AFROC-AUC	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.

Secondary Outcome Measures

Name	Time	Method
Cancer identification Sensitivity	3 months	The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
Cancer Identification Diagnosis Compliance Rate	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.
Cancer identification specificity	3 months	The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.

Trial Locations

Locations (1)

The Second Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China