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PheCheck Feasibility Study

NCT05998109 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-15

No results posted yet for this study

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

Conditions

  • Phenylketonurias

Interventions

DEVICE

PheCheck™

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

DIAGNOSTIC_TEST

HPLC Amino Acid Analyzer

1 venous specimen collected at each study visit

DIAGNOSTIC_TEST

Dried Blood Spot Cards

capillary blood specimen collected at each study visit

Sponsors & Collaborators

  • Aptatek Biosciences

    collaborator UNKNOWN

  • Lumos Diagnostics

    lead INDUSTRY

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-07-31
Completion
2024-07-31

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 NCT05998109 on ClinicalTrials.gov