Clinical Trials in the USA / NCT07383688
Recruiting
Observational
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
NCT07383688 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Urinary Urge Incontinence
Investigational drug(s) / intervention(s)
Neuspera Implantable Sacral Neuromodulation System
Neuspera Implantable Sacral Neuromodulation System: Stimulation of the Sacral Nerve
Study summary
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
Eligibility
Inclusion Criteria:
1. Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year
2. Is 22 years of age or older
3. Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
4. Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
5. Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.
Exclusion Criteria:
1. Has a contraindication for the Neuspera SNM System per the device labeling.
2. Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study
Primary outcome measure(s)
- Subject Questionnaire — 1 month
The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Specialty Clinical Research of St. Louis | St Louis | Missouri | Recruiting |
More Neuspera Medical, Inc. trials in the USA
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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 NCT07383688 on ClinicalTrials.gov ↗ ← All trials in the USA