Actively Recruiting

Age: 14Years +
All Genders
Healthy Volunteers
NCT06421844

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

Led by Air Force Military Medical University, China · Updated on 2024-05-20

270

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks. Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method. The study duration is estimated to be 3 months.

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years or older
  • Visiting the Gastroenterology Department of Xijing Hospital and undergoing liver function tests the same day
  • Diagnosed with conditions including pancreatitis, pancreatic tumors, hepatobiliary stones, biliary tumors, or colonic polyps
Not Eligible

You will not qualify if you...

  • Having diseases causing abnormal scleral color changes, such as glaucoma, Wilson's disease, pterygium, or scleritis
  • Recent consumption of large amounts of carotenoid-rich foods like oranges or carrots
  • Unable to provide informed consent
  • Incomplete scleral exposure due to limited eye movement or excessive tension during eye examination
  • Unable to understand eye rotation instructions or cooperate due to hearing problems or other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, China, 710032

Actively Recruiting

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Research Team

Y

Yanglin Pan, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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