PheCheck Feasibility Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05998109

Enrollment

Registered

2023-08-18

Start date

2023-12-15

Completion date

2024-07-31

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phenylketonurias

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), in patients with PKU. The main aims are: * Evaluate the accuracy of PheCheck as compared to the gold standard * Evaluate ease of use by lay participants

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 compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood. The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.

Interventions

DEVICEPheCheck™

Quantitative, single-use, rapid test Intended for home-based self-testing and monitoring of PKU. 1 fingerstick specimen collected at each study visit

DIAGNOSTIC_TESTHPLC Amino Acid Analyzer

1 venous specimen collected at each study visit

DIAGNOSTIC_TESTDried Blood Spot Cards

capillary blood specimen collected at each study visit

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

* 10 years of age or older * Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer	6-8 weeks	The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026