Ignite Creation Date:
2024-05-06 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05269680
Status:
RECRUITING
Last Update Posted:
2022-08-10
First Post:
2022-02-08
Brief Title:
STAR-LIFE a Post-market Registry on MINIject
Sponsor:
iSTAR Medical
Organization:
iSTAR Medical
Study Overview
Official Title:
STAR-LIFE a Post-market Registry on MINIject
Status:
RECRUITING
Status Verified Date:
2022-08
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:
STAR-LIFE
Brief Summary:
As part of the post-market clinical follow-up PMCF this registry is developed to ensure real-world data collection on MINIject device
Detailed Description:
The goal of the registry is to collect data of the MINIject in a real-life setting The registry has 3 main objectives the collection of real-world evidence on the usability of the device the patient reported outcomes and the device safety over a period of 2 years after surgery
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