NCT06885099已完成不适用
Ease of Use Study of the FemPulse System
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Patient Usability of System
研究概览
简要总结
The objective of the study is to demonstrate that the FemPulse System can be used as indicated
详细描述
The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Patient and Clinician Instructions for Use (IFU), as applicable.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms .
- •Able to read, comprehend, and reliably provide informed consent and study-related information.
- •Willing and able to comply with study required procedures and visits
排除标准
- •Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol.
- •Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator.
- •4. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.
研究组 & 干预措施
Subjects receiving the FemPulse System
Experimental
Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.
干预措施: FemPulse System (Device)
结局指标
主要结局
Patient Usability of System
时间窗: 2 days
A survery will be conducted to determine the overall usability of the system
次要结局
未报告次要终点
研究者
研究点 (1)
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