Status:
COMPLETED
PheCheck Feasibility Study
Lead Sponsor:
Lumos Diagnostics
Collaborating Sponsors:
Aptatek Biosciences
Conditions:
Phenylketonurias
Eligibility:
All Genders
10+ years
Brief Summary
The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer),...
Detailed Description
The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood ...
Eligibility Criteria
Inclusion
- 10 years of age or older
- Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent
Exclusion
- Younger than 10 years of age
- Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
- Lack of signed informed consent
- Previous enrollment in the study and has completed study visit 1 and 2
Key Trial Info
Start Date :
December 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05998109
Start Date
December 15 2023
End Date
July 31 2024
Last Update
September 15 2025
Active Locations (1)
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1
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224