NCT02399124进行中（未招募）不适用
ICE-SECRET PROSENSE™ Cryotherapy For Renal Cell Carcinoma Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure.
研究概览
简要总结
This experiment is designed for post marketing data collection of a cryosurgical system [PROSENSE™ of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
详细描述
A post marketing data collection of a cryosurgical system [PROSENSE™] of IceCure Medical], for the treatment of renal cell carcinoma (RCC).
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
- •Patient is above 18 years old.
- •The patient has enhanced solid mass of renal origin located in the kidney or elsewhere proved by imaging.
- •Patient's mass size is up to 5 cm at its largest dimension.
- •Patient is able to visit the clinic as needed during the 60-month follow-up period following the cryoablation procedure.
- •The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.
排除标准
- •Patients with permanent coagulation disorders or severe medical instability or active infection.
- •Patients with any terminal illness.
- •Patient participating in other trials using drugs or devices.
结局指标
主要结局
Success in creating an ice ball that engulfs the whole tumor with 5 mm margins using the ProSense™ as seen under laparoscopic, US or CT imaging during the procedure.
时间窗: During intervention
% of procedures with sufficient engulfment
Recurrence free survival
时间窗: up to 5 years
% of local recurrence events
次要结局
- Success in verification of the ProSense™ safety as demonstrated by having no complications related to the cryoablation procedure other than the well-known ones.(a follow up visit at 6 weeks, 6 months, 12 months and every 1 year afterwards up to 5 years)
研究者
研究点 (3)
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