Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 3:10 PM
Study NCT ID:
NCT06789406
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PMCF Study of the Axonics SNM System Model 5101 (R20)
Sponsor:
Axonics, Inc.
Organization:
Study Overview
Official Title:
Post-Market Clinical Follow-up Study of the Axonics SNM System Model 5101 (R20)
Status:
RECRUITING
Status Verified Date:
2025-12
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:
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Detailed Description:
This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: