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BiliCam Clinical Validation Study

NCT03246503 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2022-06-09

Study results available
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Summary

The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.

Conditions

  • Newborn Jaundice

Interventions

DEVICE

BiliCam estimated bilirubin (BCB)

Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • BiliCam, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Hours
Max Age
191 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2018-02-28
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246503 on ClinicalTrials.gov