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Post-Approval Study of the Neuspera Sacral Neuromodulation System

NCT07144813 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-02-04

No results posted yet for this 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.

Conditions

  • Urinary Urgency Incontinence

Interventions

DEVICE

Neuspera Implantable Sacral Neuromodulation System

Stimulation of the Sacral Nerve.

Sponsors & Collaborators

  • Neuspera Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Osvaldo Padron, MD · Florida Urology Partners

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144813 on ClinicalTrials.gov