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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470452
• Other study ID #: EndoAngel -CTP-02
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: August 2022

Study information

• Verified date: July 2022
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Song He, MD
• Phone: +8613808336120
• Email: dengchao1990[@]hospital.cqmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• The reading process is assisted by ENDOANGEL
Diagnosis of benign and malignant lesions with the help of ENDOANGEL
• No ENDOANGEL assistance during the reading process
Diagnosis of benign and malignant lesions without the help of ENDOANGEL

Locations

Country	Name	City	State
China	The Second Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AFROC-AUC	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	Cancer identification Sensitivity	The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.	3 months
Secondary	Cancer identification specificity	The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.	3 months
Secondary	Cancer Identification Diagnosis Compliance Rate	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