Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-13

Study Completion Date

2025-12-12

Brief Summary

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The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.

Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

Detailed Description

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Conditions

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Phenylketonuria Metabolic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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DM-DIV MITRA®

Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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DM-DIV HemaPEN®

Eligibility Criteria

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Inclusion Criteria

* Children aged 3 months to 18 years
* suffering from phenylketonuria or hyperphenylalaninemia
* who have had a capillary and blood test including a phenylalanine assay at CHUGA
* Whose parents or legal guardians are affiliated to the social security system.
* For whom parents or legal guardians have not objected to the MitrAlanine study.

Exclusion Criteria

* Parents or legal guardians opposed to the MitrAlanine study

Minimum Eligible Age

3 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Grenoble Alpes

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christelle CORNE, MD

Role: CONTACT

Phone: 04 76 76 92 32

Email: [email protected]

Caroline TOURNEGROS, CRA

Role: CONTACT

Phone: 04 76 76 67 30

Email: [email protected]

Facility Contacts

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Christelle CORNE

Role: primary

Other Identifiers

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2023-A01180-45

Identifier Type: OTHER

Identifier Source: secondary_id

38RC22.0319

Identifier Type: -

Identifier Source: org_study_id