Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
Study NCT ID:
NCT06153667
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Sponsor:
Merit Medical Systems, Inc.
Organization:
Study Overview
Official Title:
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
Status:
RECRUITING
Status Verified Date:
2024-11
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:
BETTER-UAE
Brief Summary:
This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: