Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421844
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
A Prospective Study Smart Phone Application for Measure Serum Bilirubin Through Sclera Images
Sponsor:
Air Force Military Medical University China
Organization:
Air Force Military Medical University China
Study Overview
Official Title:
A Prospective Study A Computer Vision Model on a Smartphone Platform for Real-time Evaluation of Serum Bilirubin Through Sclera Images
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 eg jaundice grading evaluation indicators will be analyzed using the chi-square test or Fishers exact probability test For continuous variables eg 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
Statistical differences for categorical variables eg jaundice grading evaluation indicators will be analyzed using the chi-square test or Fishers exact probability test For continuous variables eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None