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Not yet recruiting NCT07383688

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

— Observational Urinary Urge Incontinence

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuspera Implantable Sacral Neuromodulation System.
Who it may be relevant to
Registry conditions: Urinary Urge Incontinence. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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.

Interventions

  • Device Neuspera Implantable Sacral Neuromodulation System
    Stimulation of the Sacral Nerve

Primary outcome measures

  • Primary Study measure [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07383688 · Neuspera Medical (NSM-007)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗