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Bilistick Point-of-care System 2.0 Bilirubin Validation

NCT06058910 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-03-13

No results posted yet for this study

Summary

This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (\<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.

Conditions

  • Neonatal Screening
  • Kernicterus
  • Newborn Jaundice
  • Point-of-Care Testing

Interventions

DIAGNOSTIC_TEST

Bilistick System 2.0 point-of-care testing device

The routine standard-of-care blood sample collection involves a 0.5 milliliter whole blood draw by the heel stick method for bilirubin assessments under current reference clinical methodology for total bilirubin. An additional 0.035 milliliter of whole blood will be collected for measurement in the point-of-care Bilistick System 2.0 (Bilistick point-of-care testing device). The resulting Bilistick System 2.0 data (i.e., total bilirubin) will be recorded, but will not be entered into the patients' electronic medical records or used for any diagnostic or medical decision purposes.

Sponsors & Collaborators

  • Bilimetrix s.r.l.

    collaborator OTHER

  • Kettering Health Network

    lead OTHER

Principal Investigators

  • Jonathan D Toot, MD · Kettering Health

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-06-16
Completion
2024-09-09

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 NCT06058910 on ClinicalTrials.gov