PheCheck Feasibility Study

Launched by LUMOS DIAGNOSTICS · Aug 10, 2023

Keywords

ClinConnect Summary

The PheCheck Feasibility Study is a clinical trial aimed at testing a new tool called PheCheck™ that quickly measures phenylalanine (Phe) levels. This study compares how well PheCheck works against a standard laboratory method called HPLC amino acid analyzer, which is currently the best way to measure Phe levels in people with phenylketonuria (PKU). The goal is to see if PheCheck is accurate and easy to use for patients and their families.

To participate in this study, individuals must be at least 10 years old and currently being monitored for PKU, hyperphenylalaninemia, or PKU during pregnancy. Participants will be asked to use the PheCheck tool and provide feedback on their experience. This study is currently recruiting, and both males and females are welcome to join. If you or someone you know meets the eligibility criteria, this could be an opportunity to help improve how PKU is managed.

Gender

ALL

Eligibility criteria

• 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