Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347380
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Brief Title:
Usability Study of the FemPulse System
Sponsor:
FemPulse Corporation
Organization:
FemPulse Corporation
Study Overview
Official Title:
Usability Study of the FemPulse System
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use IFU as applicable
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None