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

C

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)

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

Trial contacts and locations

1

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Central trial contact

Song He, MD

Data sourced from clinicaltrials.gov

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