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

NCT ID: NCT05470452

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Physician AI-assisted diagnosis group

Group Type EXPERIMENTAL

The reading process is assisted by ENDOANGEL

Intervention Type OTHER

Diagnosis of benign and malignant lesions with the help of ENDOANGEL

Physician Independent Diagnostic Group

Group Type SHAM_COMPARATOR

No ENDOANGEL assistance during the reading process

Intervention Type OTHER

Diagnosis of benign and malignant lesions without the help of ENDOANGEL

Interventions

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The reading process is assisted by ENDOANGEL

Diagnosis of benign and malignant lesions with the help of ENDOANGEL

Intervention Type OTHER

No ENDOANGEL assistance during the reading process

Diagnosis of benign and malignant lesions without the help of ENDOANGEL

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Song He, MD

Role: CONTACT

+8613808336120

Facility Contacts

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Chao Deng

Role: primary

+8615123172616

Other Identifiers

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EndoAngel -CTP-02

Identifier Type: -

Identifier Source: org_study_id

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