Real-World Registry - The Vivally® System
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Real-world Usage
研究概览
简要总结
This is a Real-World Registry Study to collect real-world dosing, utilization, demographic, quality of life, and data from the e-bladder diaries of patients utilizing the Vivally® System. Data points will be drawn from the Avation Medical HIPAA-compliant cloud database including but not limited to:
Therapy compliance and stimulation metrics
Diary entries provided by patients
Various questionnaires
Participants have the option to opt out of allowing their data to be part of any publication at any time.
详细描述
Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.
Gather feedback from patients on their experience and satisfaction with the Vivally® System therapy
Identify trends in dosing, compliance, and therapy parameters in order to optimize the wearable, Vivally® System neuromodulation therapy for participants
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
- •To be eligible for the Real-World Registry Study, Participants must satisfy all of the following criteria:
- •Are an appropriate candidate for the Vivally® System as determined, and prescribed by a licensed clinical professional
- •Have provided informed consent to have their data included in publications associated with this study
排除标准
- •While it is up to the discretion of the clinician to prescribe the Vivally® System for a specific patient, the Vivally® System is contraindicated for use on patients who have the following history or conditions:
- •Patients with pacemakers of implanted defibrillators
- •Patients with nerve damage that could impact either transcutaneous tibial nerve stimulation or pelvic floor function
- •This product is not intended for intra-cardiac or trans-thoracic use
- •Additional contraindications, warnings and precautions are listed in the User Guide.
结局指标
主要结局
Real-world Usage
时间窗: Length of Study, on average 20 years
Collect real-world dosing, utilization, demographics and quality of life data from the eDiaries of patients utilizing the Vivally® System.
次要结局
- Prescribing Trends(Length of Study, on average 20 years)
- Patient Satisfaction(Length of Study, on average 20 years)
- Patient Compliance(Length of Study, on average 20 years)