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

Chongqing Medical University

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Other: The reading process is assisted by ENDOANGEL; Other: No ENDOANGEL assistance during the reading process

Study type: Interventional

Funder types: Other

Identifiers

NCT05470452

EndoAngel -CTP-02

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 2 patient groups

Physician AI-assisted diagnosis group

Experimental group

Treatment:

Other: The reading process is assisted by ENDOANGEL

Physician Independent Diagnostic Group

Sham Comparator group

Treatment:

Other: No ENDOANGEL assistance during the reading process