NCT07383688

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Neuspera Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Urge Incontinence

Interventions

Type	Name	Description
DEVICE	Neuspera Implantable Sacral Neuromodulation System	Stimulation of the Sacral Nerve

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2026-02-03
• Last updated: 2026-03-05

Regulatory

• FDA-regulated device study