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NCT04131530 Clinical Trial

Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence

Ulcerative Colitis Clinical Trial

Official title:
Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04131530
Other study ID # 2019SDU-QILU-10
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2019
Est. completion date December 2019

Study information
Verified date October 2019
Source Shandong University
Contact Yanqing Li
Phone 053182169385
Email liyanqing@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- aged between 18 and 80; diagnosed as UC

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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• The diagnosis of Artificial Intelligence and endoscopist
When the colon mucosa is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.

Locations
Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The diagnosis efficiency of Artificial Intelligence The primary outcome is to test the diagnostic accuracy, sensitivity, specificity, PPV, NPV of the Artificial Intelligence for evaluation of inflammation activity of UC on pCLE examination. 3 months
Secondary Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists The secondary outcome is to compare the diagnosis efficiency (including diagnostic accuracy, sensitivity, specificity, PPV, NPV ) between Artificial Intelligence and endoscopists. 3 months
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