Status:

RECRUITING

A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images

Lead Sponsor:

Air Force Military Medical University, China

Conditions:

Jaundice

Deep Learning

Eligibility:

All Genders

14+ years

Brief Summary

The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the...

Eligibility Criteria

Inclusion Criteria:

Age 14 years or older. Subjects who are visiting the Gastroenterology Department of Xijing Hospital and will undergo liver function tests on the same day. The disease spectrum of the subjects mainly includes pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, and colonic polyps.

Exclusion Criteria:

Subjects with diseases that may cause abnormal changes in scleral color, such as glaucoma, Wilson's disease, pterygium, or scleritis.

Subjects who have recently consumed a large amount of carotenoid-rich foods (such as oranges or carrots).

Subjects who are unable to provide informed consent.

Elimination Criteria:

Subjects with incomplete scleral exposure due to limited eye movement or excessive tension during external eye examination.

Subjects who are unable to understand the instructions for eye rotation during scleral examination or are unable to cooperate due to reasons such as poor hearing.

Key Trial Info

Start Date :

April 20 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 10 2024

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT06421844

Start Date

April 20 2024

End Date

July 10 2024

Last Update

May 20 2024

Active Locations (1)

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First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China, 710032