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

NCT06940193 | Enrolling By Invitation

• 1 other identifier: IRAS ID 350589
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phenylketonuria (PKU)

Keywords

phenylketonuria; phenylalanine; Phe; Self-test

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is blood phenylalanine.

  A drop of blood (40ul) is collected by the patient using a patient led home testing device (study device). The result is compared with a parallel collected blood sample on a dried blood spot (DBS) card which is analyzed in a lab using tandem mass spectrometry (standard practice).

  Monitoring of patient phenylalanine levels for 6 months.

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients with PKU (3-17 years of age)

You may qualify if:

• All individuals with PKU aged 3 years and over
• Subjects with a confirmed diagnosis of PKU detected from newborn screening
• Healthy adult volunteers (\>18 years of age) without PKU
• Male and female subjects will be included in this study.

You may not qualify if:

• Children under the age of 3 years
• Individuals with needle phobia
• Patients with comorbidities that may affect tolerance of blood sampling e.g. autism or other neurodiversity disorders
• Patients with acute illness e.g. chicken pox, tonsillitis requiring antibiotics
• Patients with chronic illness and taking long term medications e.g. diabetes.

Sponsors & Collaborators

• Egoo Health Aps: lead

Study Sites (1)

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, B4 6NH, United Kingdom

Location

MeSH Terms

Conditions

Phenylketonurias

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anita MacDonald

  Birmingham Women's and Children's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 23, 2025
• Study Start: April 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 31, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

GB (1)