Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369740
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring
Sponsor:
Enzyre BV
Organization:
Enzyre BV
Study Overview
Official Title:
Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study consists of two parts
In part one case scenario focus groups with hemophilia A patients and healthcare providers HCPs will be held This parts aims to identify potential use scenarios of a point of care POC in vitro medical for patients with hemophilia A The main questions it aims to answer are
How is coagulation lab testing for patients with hemophilia A currently organized
What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A
Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device The main goal of this part is to evaluate the usability of the current prototypes of the POC device
In part one case scenario focus groups with hemophilia A patients and healthcare providers HCPs will be held This parts aims to identify potential use scenarios of a point of care POC in vitro medical for patients with hemophilia A The main questions it aims to answer are
How is coagulation lab testing for patients with hemophilia A currently organized
What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A
Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device The main goal of this part is to evaluate the usability of the current prototypes of the POC device
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None