Evaluation of Capillary Blood Collection Devices (Mitra®... | NCT05894122

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

NCT05894122

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Dec 22, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Phenylketonuria
Metabolic Diseases

Interventions

DM-DIV MITRA®

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2023-A01180-45	Other Identifier	ID RCB

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2023Actual

Primary Completion Date

Dec 12, 2025Estimated

Completion Date

Dec 12, 2025Estimated

First Submitted Date

May 30, 2023

First Submission Date that Met QC Criteria

Jun 7, 2023

First Posted Date

Jun 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2023

Last Update Posted Date

Dec 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DM-DIV MITRA®	Diagnostic Test	Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).		DM-DIV HemaPEN®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of phenylalanine concentrations	Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Ease of use of research device	ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers	Day 1
sample conformity	Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christelle CORNE, MD	Contact	04 76 76 92 32	+33	CCorne@chu-grenoble.fr
Caroline TOURNEGROS, CRA	Contact	04 76 76 67 30	+33	CTournegros@chu-grenoble.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Grenoble Alpes	Recruiting	Grenoble		38043	France

Condition Browse Module

MeSH Terms

ID	Term
D010661	Phenylketonurias
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D020739	Brain Diseases, Metabolic, Inborn
D001928	Brain Diseases, Metabolic
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided