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Post-Approval Study of the Neuspera Sacral Neuromodulation System

Study acronym: NSM-005
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 20
    • Start date changed from estimate of Sep 2025 to Sep 3, 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 approval of the Neuspera SNM System. Participants in this study received intervention/implanted in Phase I or Phase II of the Neuspera SANS\_UUI (NSM-004) Study.
Trial Details
NCT Number NCT07144813
Lead Sponsor Neuspera Medical, Inc.
Conditions
(from sponsor)		 Urinary Urgency Incontinence
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov