Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-08 @ 9:43 PM
Study NCT ID:
NCT06597994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmenting Urinary Reflex Activity: Study 3
Sponsor:
Amber Therapeutics Ltd
Organization:
Study Overview
Official Title:
Therapy Optimisation Study of Adaptive Pudendal Neuromodulation in Women With Urinary Incontinence Implanted With the Amber UI System.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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:
AURA-3
Brief Summary:
AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.
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?: