Post-Approval Study of the Neuspera Sacral Neuromodulation System

Part of paid clinical trials in San Diego, California.

Sponsor
Neuspera Medical, Inc.
Study ID
NCT07144813
Status
Recruiting
Apply to this trial

Conditions

  • Urinary Urgency Incontinence

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neuspera Implantable Sacral Neuromodulation System — DEVICE
    Stimulation of the Sacral Nerve.

Study Details

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.

Key Dates

Start date
Sep 3, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
116 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Neuspera Implantable Sacral Neuromodulation Stimulation System
    Long term follow-up for the FDA approved Neuspera Sacral Neuromodulation Stimulation system

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: Through 72 months ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Genesis Healthcare PartnersSan DiegoCalifornia92123-
Kaiser Permanente Point Loma MOBSan DiegoCalifornia92110-
Florida Urology PartnersTampaFlorida33615-
Women's Health Advantage,Fort WayneIndiana46825-
Indiana University, School of MedicineIndianapolisIndiana46202-
University of Kansas Medical Center,Kansas CityKansas66160-
University of Louisville Health System,LouisvilleKentucky40202-
Ochsner MedicalNew OrleansLouisiana70121-
University of Michigan HealthWyomingMichigan49519-
Minnesota UrologyWoodburyMinnesota55125-
Specialty Research of St. LouisSt LouisMissouri63141-
Adult & Pediatric Urology P.COmahaNebraska68114-
Premier Medical Group,PoughkeepsieNew York12603-
MetroHealth System,ClevelandOhio44109-
Women's Healthcare Associates,PortlandOregon97225-
The Institute for Female Pelvic Medicine and Reconstructive Surgery,North WalesPennsylvania19454-
Southern Urogynecology,West ColumbiaSouth Carolina29169-
Urology Austin,AustinTexas78759
Brian Mazzarella, MD
(502)-569-7904
Michelle Valentin-Rivera
(502)-569-7904
UCNT Dallas,DallasTexas75231-
Virginia Mason Medical Center,SeattleWashington98101-

Find similar trials in San Diego, CA

By research site
Genesis Healthcare Partners· San Diego, CAKaiser Permanente Point Loma MOB· San Diego, CAFlorida Urology Partners· Tampa, FLWomen's Health Advantage· Fort Wayne, INIndiana University, School of Medicine· Indianapolis, INUniversity of Kansas Medical Center· Kansas City, KS

Related Studies