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Blood Collection for Development and Validation of Point-of-Care Diagnostic Liver Function Tests

NCT05457543 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-07-14

No results posted yet for this study

Summary

This is an observational study exploring the performance of a novel point-of-care diagnostic testing platform designed to quantitate the presence of liver function biomarkers such as bilirubin. Blood samples will be collected from participants to further development and validation of the testing platform to support FDA review. The diagnostic device is intended to provide rapid in-office test results using a finger stick of blood, a reaction test device, and a smartphone app.

Conditions

Interventions

DIAGNOSTIC_TEST

Adult

Investigational use of a novel liver function diagnostic test that involves a paper-based test device and a smartphone application.

Sponsors & Collaborators

  • Group K Diagnostics Inc.

    lead INDUSTRY

Principal Investigators

  • Laura M Ferguson, PhD · Group K Diagnostics Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-12-31
Completion
2023-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05457543 on ClinicalTrials.gov