Follow-up Revision Experience and Evaluation of Device Outcomes Metrics in Subjects Receiving Replacement of Traditional Sacral Neuromodulation (SNM) With the Neuspera SNM System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Primary Study measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Neuspera Replacement Cohort
Subjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM System
干预措施: Neuspera Implantable Sacral Neuromodulation System (Device)
结局指标
主要结局
Primary Study measure
时间窗: 1 month
The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems
次要结局
未报告次要终点