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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07383688

Enrollment

100

Registered

2026-02-03

Start date

2026-03-01

Completion date

2026-10-01

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Urge Incontinence

Brief 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.

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

DEVICENeuspera Implantable Sacral Neuromodulation System

Stimulation of the Sacral Nerve

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Contacts

CONTACTMark Vollmer

mark.vollmer@neuspera.com408-433-3839

CONTACTShital Patel

shital.patel@neuspera.com3235281320

PRINCIPAL_INVESTIGATORKellen Choi, DO

University of Louisville Health System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026