DRKS00031972
Not yet recruiting
Not Applicable
Study to evaluate the reliability and practicability of the PKU Sensor and PKU App in home settings of patients with phenylketonuria - PKU Sensor
niversity Hospital Heidelberg0 sites50 target enrollmentJune 5, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- E70.0
- Sponsor
- niversity Hospital Heidelberg
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Genetically confirmed phenylalanine hydroxylase deficiency
- •Patients or their parents are capable to give informed consent (written informed consent, signed and dated)
- •Willing and able to comply with the protocol and study procedures
- •Male/ female/diverse patients
- •Newborns (after birth until the end of the 4th week of life
- •Toddlers (5th week of life to the end of the 1st year of life)
- •Infants (1st to the end of the 5th year of life)
- •Children (6th to the end of the 11th year)
- •Adolescents (from the age of 12 to the end of 17\)
- •Adults (18\-99 years)
Exclusion Criteria
- •The individual, in the opinion of the investigator, is unwilling or unable to adhere to the requirements of the study
- •Any other know genetic disorder in amino acid metabolism
- •Participation in interventional clinical studies
- •Mentally disabled persons that are needing a legal representative
Outcomes
Primary Outcomes
Not specified
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