NCT07383688 · Neuspera Medical, Inc.
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
What this study is about
Single-treatment group$1 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.
View original scientific description
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.
Interventions
DEVICE
Neuspera Implantable Sacral Neuromodulation System
Stimulation of the Sacral Nerve
Primary outcome measures
Subject Questionnaire
Time frame: 1 month
The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Is 22 years of age or older
- Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system
- Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling
- Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.
Exclusion criteria
- Has a contraindication for the Neuspera SNM System per the device labeling.
- Has plans to enroll or is currently enrolled in another investigational device or drug trial during his/her participation in this study
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2026 · Source of record for eligibility and locations