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NCT04232696 · ClinicalTrials.gov registry record · NA
Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
A NA study of Urinary Urgency Incontinence, sponsored by Neuspera Medical.
- Active
- Registry status
- NA
- Development phase
- 331
- Enrollment target
- 20
- Study locations
NCT04232696 is a NA study of Urinary Urgency Incontinence that is active but no longer recruiting, run by Neuspera Medical. The registered enrollment target is 331 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT04232696, a NA study of Urinary Urgency Incontinence, is active but no longer recruiting, sponsored by Neuspera Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 331 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases. Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial. Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.
Conditions Studied
Interventions
- DEVICE Neuspera Implantable Sacral Nerve Stimulation System
Study Locations (20)
California
- Genesis Healthcare Partners - Encinitas
- Kaiser Permanente, LAMC - Los Angeles
- Kaiser Permanente - San Diego
Florida
- Clinical Research Center of Florida - Pompano Beach
- Florida Urology Partners, LLC - Tampa
Georgia
- Midtown Urology - Atlanta
- Meridian Clinical Research - Savannah
Indiana
- Women's Health Advantage - Fort Wayne
- Indiana University School of Medicine - Indianapolis
Minnesota
- University of Minnesota - Minneapolis
- Minnesota Urology - Woodbury
New York
- Weill Cornell Medical College - New York
- Premier Medical Group - Poughkeepsie
Illinois
- Comprehensive Urologic Care - Lake Barrington
Kansas
- University of Kansas Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04232696
The ClinicalTrials.gov registry entry for NCT04232696 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neuspera Medical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Urinary Urgency Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Neuspera Implantable Sacral Nerve Stimulation System is the first listed.
NCT04232696 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04232696 about?
NCT04232696 is a clinical study titled "Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)". Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases. Objective of Phase I: To assess the utilization of the system during the Sac...
What is the current status of trial NCT04232696?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 331 participants. The study started on 2019-12-13. Estimated completion is 2026-12.
What conditions does trial NCT04232696 study?
This clinical trial studies the following conditions: Urinary Urgency Incontinence.
What interventions are being tested in trial NCT04232696?
The interventions under investigation include: Neuspera Implantable Sacral Nerve Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT04232696?
This trial is sponsored by Neuspera Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04232696 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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