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NCT Number: NCT07383688

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

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.

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Key information

Conditions

Urinary Urge Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuspera Implantable Sacral Neuromodulation System

Device

Stimulation of the Sacral Nerve

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Vollmer

CONTACT

[email protected]

408-433-3839

Shital Patel

CONTACT

[email protected]

3235281320

Sponsors and collaborators

Lead sponsor

Neuspera Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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