Status:
ENROLLING_BY_INVITATION
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
Lead Sponsor:
Egoo Health Aps
Conditions:
Phenylketonuria (PKU)
Eligibility:
All Genders
Up to 3 years
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 individua...
Detailed Description
The Egoo Phe System is intended to be used by Healthcare Professionals in the hospital, for near-patient testing in the home of the PKU patients, and for self-testing guided by the manufacturer's inst...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06940193
Start Date
April 15 2025
End Date
October 31 2025
Last Update
April 23 2025
Active Locations (1)
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1
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom, B4 6NH