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Transcutaneous Bilirubinometry in Neonates With Bilicare System

NCT02372058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2015-09-11

Study results available
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Summary

The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.

Conditions

  • We Will Focus on Assessing the Clinical Performance of the BiliCare Device

Interventions

DEVICE

BiliCare

Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device

Sponsors & Collaborators

  • Gerium Medical

    lead OTHER

Principal Investigators

  • David Schutzman, MD · Einstein Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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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 NCT02372058 on ClinicalTrials.gov