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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05470452

Enrollment

340

Registered

2022-07-22

Start date

2021-07-28

Completion date

2022-08-31

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

OTHERThe reading process is assisted by ENDOANGEL

Diagnosis of benign and malignant lesions with the help of ENDOANGEL

OTHERNo ENDOANGEL assistance during the reading process

Diagnosis of benign and malignant lesions without the help of ENDOANGEL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 specificity	3 months	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	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.

Countries

China

Contacts

Primary ContactSong He, MD

dengchao1990@hospital.cqmu.edu.cn+8613808336120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026