Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Overall Feasibility
研究概览
简要总结
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
详细描述
The trial system is used to determine if patients are responsive to sacral neuromodulation (SNM) prior to receiving the Axonics implantable neurostimulator (INS) which is approved for the treatment of OAB and FI. This study is evaluating the feasibility and safety of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provides written informed consent prior to trial procedures
- •Primary indication of OAB (UUI/UF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU
排除标准
- •Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits
- •Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function
- •Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
- •Current symptomatic urinary tract infection (UTI)
研究组 & 干预措施
Patients diagnosed with OAB and/or FI who are candidates for Axonics SNM (PNE) procedure
External trial system used evaluated whether patients with OAB or FI will be responsive to sacral neuromodulation.
干预措施: Axonics External Trial System (ETS) (Device)
结局指标
主要结局
Overall Feasibility
时间窗: Day 5-7
Trial system success rate, defined as the proportion of participants with the Axonics ETS still attached and operable end of the trial period.
Adverse Events reporting (Safety)
时间窗: Day 0-7
Device- or procedure-related adverse events as determined by the independent physician adjudicated (IPA).
次要结局
未报告次要终点