Clinical Trials in the USA / NCT07144813
Recruiting
Not applicable
Post-Approval Study of the Neuspera Sacral Neuromodulation System
NCT07144813 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Urinary Urgency Incontinence
Investigational drug(s) / intervention(s)
Neuspera Implantable Sacral Neuromodulation System
Neuspera Implantable Sacral Neuromodulation System: Stimulation of the Sacral Nerve.
Study 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 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.
Eligibility
Inclusion Criteria:
* Subjects in the SANS-UUI Phase I or Phase II study
Exclusion Criteria:
* None
Primary outcome measure(s)
- Primary Safety Endpoint — Through 72 months
Incidence of device- and procedure-related AEs - Primary Effectiveness Endpoint: — Through 72 months
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Kaiser Permanente Point Loma MOB | San Diego | California | Active Not Recruiting |
| Genesis Healthcare Partners | San Diego | California | Active Not Recruiting |
| Florida Urology Partners | Tampa | Florida | Active Not Recruiting |
| Women's Health Advantage, | Fort Wayne | Indiana | Active Not Recruiting |
| Indiana University, School of Medicine | Indianapolis | Indiana | Active Not Recruiting |
| University of Kansas Medical Center, | Kansas City | Kansas | Active Not Recruiting |
| University of Louisville Health System, | Louisville | Kentucky | Active Not Recruiting |
| Ochsner Medical | New Orleans | Louisiana | Active Not Recruiting |
| University of Michigan Health | Wyoming | Michigan | Active Not Recruiting |
| Minnesota Urology | Woodbury | Minnesota | Active Not Recruiting |
| Specialty Research of St. Louis | St Louis | Missouri | Active Not Recruiting |
| Adult & Pediatric Urology P.C | Omaha | Nebraska | Active Not Recruiting |
| Premier Medical Group, | Poughkeepsie | New York | Active Not Recruiting |
| MetroHealth System, | Cleveland | Ohio | Active Not Recruiting |
| Women's Healthcare Associates, | Portland | Oregon | Active Not Recruiting |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery, | North Wales | Pennsylvania | Active Not Recruiting |
| Southern Urogynecology, | West Columbia | South Carolina | Active Not Recruiting |
| Urology Austin, | Austin | Texas | Recruiting |
| UCNT Dallas, | Dallas | Texas | Active Not Recruiting |
| Virginia Mason Medical Center, | Seattle | Washington | Active Not Recruiting |
More Neuspera Medical, Inc. trials in the USA
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07144813 on ClinicalTrials.gov ↗ ← All trials in the USA