Post-Approval Study of the Neuspera Sacral Neuromodulation System
NCT ID: NCT07144813
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
116 participants
INTERVENTIONAL
2025-09-30
2029-12-31
Brief Summary
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Participants in this study received intervention/implanted in Phase I or Phase II of the Neuspera SANS\_UUI (NSM-004) Study.
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Detailed Description
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This post approval study (PAS) is designed to assess the long-term safety and effectiveness data out to 72 months post-implant, in consenting subjects implanted in Phase I or Phase II study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neuspera Implantable Sacral Neuromodulation Stimulation System
Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system
Neuspera Implantable Sacral Neuromodulation System
Stimulation of the Sacral Nerve.
Interventions
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Neuspera Implantable Sacral Neuromodulation System
Stimulation of the Sacral Nerve.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
22 Years
ALL
No
Sponsors
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Neuspera Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Osvaldo Padron, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Urology Partners
Central Contacts
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Related Links
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Neuspera Medical web page
Other Identifiers
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Neuspera Medical (NSM-005)
Identifier Type: -
Identifier Source: org_study_id
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