Skip to main content
Clinical Trials/NCT03787784
NCT03787784UnknownNot Applicable

Automatic Classification of Colorectal Polyps Using Probe-based Endomicroscopy With Artificial Intelligence

Shandong University1 site in 1 country200 target enrollmentStarted: May 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
The accuracy of classifying colorectal Polyps using Probe-based endomicroscopy with deep neural networks

Study Overview

Brief Summary

Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables real-time histological evaluation of gastrointestinal mucosa during ongoing endoscopy examination. It can predict the classification of Colorectal Polyps accurately. However this requires much experience, which limits the application of pCLE. The investigators designed a computer program using deep neural networks to differentiate hyperplastic from neoplastic polyps automatically in pCLE examination.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

AI visible group

Experimental

Intervention: AI presentation (Other)

AI invisible group

No Intervention

Outcomes

Primary Outcomes

The accuracy of classifying colorectal Polyps using Probe-based endomicroscopy with deep neural networks

Time Frame: 4 months

The primary outcome is to test the diagnostic accuracy, sensitivity, specificity, PPV, NPV of the Artificial Intelligence for diagnosing Colorectal Polyps on real-time pCLE examination.

Secondary Outcomes

  • Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists(3 month)

Investigators

Sponsor
Shandong University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yanqing Li

Vice president of QiLu Hospital

Shandong University

Study Sites (1)

Loading locations...

Similar Trials