Neuspera Replacement Survey Study

N/ANot Yet RecruitingNCT07383688

Neuspera Medical, Inc.20 enrolled

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.

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

Conditions

Urinary Urge Incontinence

Interventions

Neuspera Implantable Sacral Neuromodulation SystemDEVICE

Stimulation of the Sacral Nerve

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Primary Study measure

The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems

Time frame: 1 month

Central Contacts

Mark Vollmer

CONTACT

408-433-3839 mark.vollmer@neuspera.com

Shital Patel

CONTACT

3235281320 shital.patel@neuspera.com

Data from ClinicalTrials.gov

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