FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics

March 3, 2026 updated by: Neuspera Medical, Inc.

Follow-up Revision Experience and Evaluation of Device Outcomes Metrics in Subjects Receiving Replacement of Traditional Sacral Neuromodulation (SNM) With the Neuspera SNM System

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will be enrolled in a single-arm study and followed for 1-month after implant of the Neuspera SNM System.

Subjects will complete a questionnaire regarding their experience with the traditional SNM system prior to the Neuspera implant, then undergo an implant of the Neuspera SNM system using standard of care according to the device's commercial labeling.

Up to 20 subjects will be enrolled.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population with 22 years of age or older and who have or have previously had a traditional SNM system.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neuspera Replacement Cohort
Subjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM System
Device: Neuspera Implantable Sacral Neuromodulation System
Stimulation of the Sacral Nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Study measure
Time Frame: 1 month
The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuspera Medical, Inc.

Investigators

  • Principal Investigator: Kellen Choi, DO, University of Louisville Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuspera Medical (NSM-007)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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