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A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images - Trial NCT06421844

Access comprehensive clinical trial information for NCT06421844 through Pure Global AI's free database. This phase not specified trial is sponsored by Air Force Military Medical University, China and is currently Recruiting. The study focuses on Jaundice,Deep Learning,Hyperbilirubinemia,Sclera. Target enrollment is 270 participants.

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NCT06421844
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Trial Details
ClinicalTrials.gov โ€ข NCT06421844
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A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images
A Prospective Study: A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images

Study Focus

Observational

Sponsor & Location

Air Force Military Medical University, China

Xi'an, China

Timeline & Enrollment

N/A

Apr 20, 2024

Jul 10, 2024

270 participants

Primary Outcome

Loss of predicted bilirubin levels,Classification accuracy

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 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.

ICD-10 Classifications

Hyperbilirubinaemia with mention of jaundice, not elsewhere classified
Hyperbilirubinaemia, with or without jaundice, not elsewhere classified
Hyperbilirubinaemia without mention of jaundice, not elsewhere classified
Neonatal jaundice, unspecified
Neonatal jaundice from other specified causes

Data Source

ClinicalTrials.gov

NCT06421844

Non-Device Trial