Status:
NOT_YET_RECRUITING
Post-Approval Study of the Neuspera Sacral Neuromodulation System
Lead Sponsor:
Neuspera Medical, Inc.
Conditions:
Urinary Urgency Incontinence
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approva...
Detailed Description
The Neuspera SNM System received FDA PMA approval for the treatment of urinary urge incontinence in subjects who have failed, could not tolerate, or were not a candidate for more conservative treatmen...
Eligibility Criteria
Inclusion
- Subjects in the SANS-UUI Phase I or Phase II study
Exclusion
- None
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT07144813
Start Date
September 1 2025
End Date
December 1 2029
Last Update
August 28 2025
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