Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 5
- 主要终点
- Performance/effectiveness - Improvement in Quality of Life scoring (FI)
研究概览
简要总结
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
详细描述
Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Primary indication of Fecal Incontinence (FI)
- •Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers
排除标准
- •Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis)
- •Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements
- •History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
- •A female who is breastfeeding
- •A female with a positive urine pregnancy test
研究组 & 干预措施
Fecal Incontinence
Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms.
干预措施: Axonics SNM System INS Model 5101 (R20) (Device)
结局指标
主要结局
Performance/effectiveness - Improvement in Quality of Life scoring (FI)
时间窗: 3 months
Short-term FI improvement demonstrated by Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence.
Performance/effectiveness - Improvement in patient satisfaction scoring (FI)
时间窗: 3 months
Short-term FI improvement demonstrated by Participant Satisfaction with Treatment and Charging Questionnaire. Participants will indicate satisfaction with SNM therapy for treatment of their FI symptoms based on a 7-point Likert scale ranging from "Very satisfied" to "Very dissatisfied".
次要结局
- Performance/effectiveness - Improvement in Quality of Life scoring (FI)(12 months, 24 months)
- Performance/effectiveness - Improvement in Quality of Life scoring (FI)(3 months, 12 months, 24 months)
- Performance/effectiveness - Improvement in patient satisfaction scoring (FI)(12 months)
- Adverse event reporting (Safety)(3 months, 12 months, 24 months)
- Performance/effectiveness - Improvement in Quality of Life scoring (FI)(12 months)
- Performance/effectiveness - Improvement in Quality of Life scoring (FI)(3 months, 12 months)
- Adverse event reporting (Safety)(3 months, 12 months)