Automatic Real-time Diagnosis of Gastric Mucosal Disease Using pCLE With Artificial Intelligence

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

COMPLETED

Total Enrollment

951 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-09-29

Brief Summary

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Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables real-time histological evaluation of gastric mucosal disease during ongoing endoscopy examination. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.

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Detailed Description

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Conditions

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Gastric Diseases Artificial Intelligence Confocal Laser Endomicroscopy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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lesions observed by pCLE

pCLE is used to distinguish the suspected lesions detected by white light endoscopy.

The diagnosis of Artificial Intelligence and endoscopist

Intervention Type DIAGNOSTIC_TEST

When suspected lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.

Interventions

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The diagnosis of Artificial Intelligence and endoscopist

When suspected lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* aged between 18 and 80;
* agree to give written informed consent.

Exclusion Criteria

* Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium;
* Inability to provide informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No