Vanquish® Water Vapor Ablation for PrOstate CanceR: Long-Term Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 4
- 主要终点
- Primary Safety Outcome
研究概览
简要总结
The purpose of the registry is to evaluate real-world safety, efficacy, and patient reported outcomes among participants receiving Vanquish Water Vapor Ablation System therapy (Vanquish Therapy). This includes longitudinal assessment of patients who have received or will receive the therapy one or multiple times as part of routine clinical care and encompasses those who completed a company-sponsored Vanquish therapy study (as applicable).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Candidate for Vanquish therapy per physician discretion or participant has completed a company-sponsored Vanquish therapy study.
- •Participant is willing and able to provide written informed consent.
排除标准
- •Contraindications per the Vanquish IFU
- •Previously participated in VAPOR 2 study and is not planning to receive further Vanquish therapy.
研究组 & 干预措施
Vanquish Procedure Patients
Patients that have completed or will complete a Vanquish therapy and plan to continue their routine clinical care.
干预措施: Vanquish Therapy (Device)
结局指标
主要结局
Primary Safety Outcome
时间窗: Through study completion, or up to 15 years
Rate of complications classified as Clavien-Dindo grades III-V and attributable to the Vanquish procedure and/or device over time. * Grade III: Complications requiring surgical intervention (IIIa: laparoscopic, IIIb: open). * Grade IV: Life-threatening complications (IVa: single organ failure, IVb: multi-organ failure). * Grade V: Death of a patient.
Primary Efficacy Outcome
时间窗: Through study completion, or up to 15 years.
Freedom from disease specific mortality.
次要结局
未报告次要终点