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

NCT05470452 | Unknown

• 1 other identifier: EndoAngel -CTP-02
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cancer identification Sensitivity

  3 months

• Cancer identification specificity

  3 months

• Cancer Identification Diagnosis Compliance Rate

  3 months

Study Arms (2)

Physician AI-assisted diagnosis group

EXPERIMENTAL

Other: The reading process is assisted by ENDOANGEL

Physician Independent Diagnostic Group

SHAM COMPARATOR

Other: No ENDOANGEL assistance during the reading process

Interventions

The reading process is assisted by ENDOANGEL OTHER

Diagnosis of benign and malignant lesions with the help of ENDOANGEL

Physician AI-assisted diagnosis group

No ENDOANGEL assistance during the reading process OTHER

Diagnosis of benign and malignant lesions without the help of ENDOANGEL

Physician Independent Diagnostic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18, male or female；
• Cases with complete, clear imaging data, including images under white light and magnified stained images；
• Complete pathological diagnosis of upper digestive tract lesions;
• The included cases were excluded from the software development.

You may not qualify if:

• Cases whose image data did not meet the evaluation requirements;
• The investigator considered the case unsuitable for the clinical trial.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Song He, MD

CONTACT

+8613808336120; dengchao1990@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: July 28, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

CN (1)