Clinical Trial

A Self-test Home-use Blood Phenylalanine Monitoring System Under the Brand Name Egoo Phe System Has Been Developed for Measurement of Phenylalanine (Phe) in Individuals Diagnosed With Phenylketonuria (PKU): The Study Purpose is to Evaluate Accuracy and Usability

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Record status
This record was last updated April 23, 2025 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
A home-use self-test blood phenylalanine monitoring system under the brand name Egoo Phe System from manufacturer Egoo Health Aps has been developed for measurement of phenylalanine (Phe) in individuals diagnosed with phenylketonuria (PKU). This home monitor is intended to be an adjunct to current clinical practice in the management of individuals with PKU. The objective of this investigation is to perform multi blood comparison studies between the Egoo Phe System and the standard analytical methods (finger prick blood spots) to demonstrate the Egoo Phe System's accuracy.
Trial Details
NCT Number NCT06940193
Lead Sponsor Egoo Health Aps
Conditions Phenylketonuria (PKU)
Enrollment 20 participants
Start Date 2025-04-15
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-23