A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.
研究概览
简要总结
Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney) tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most common technique is to clamp the blood supply to the entire kidney during removal and to surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood supply to the entire kidney including the healthy tissue, which can cause damage to the remaining tissue due to a shortage of oxygen if left clamped too long.
This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading to the remaining tissue, clamping and a shortage of oxygen can be avoided.
The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage of bleeding during partial kidney removal.
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 must have a solitary, polar, clinical T1 renal mass
- •Patient must have adequate kidney function as measured by eGFR (estimated glomerular filtration rate) greater than or equal to 50 calculated from a standard care serum creatinine performed within 30 days prior to the partial nephrectomy operation.
- •Women of child-bearing potential must have negative serum or urine pregnancy test
- •Patient must be able to give written informed consent
- •Patient must be 18 years or older
- •No blood-thinning medications, including anti-inflammatory medications, herbs and supplements for at least 1 week prior to surgery
排除标准
- •T stage greater than clinical T1
- •Tumor extends beyond kidney into major veins, perinephric tissues, or adrenal gland
- •Prior surgery or radiation therapy to the region of interest
- •Patient has a single functioning kidney
- •Patient has an uncorrectable coagulopathy
- •Patient is not a surgical candidate due to underlying cardiac or other serious comorbid condition
研究组 & 干预措施
Certus 140™
During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.
干预措施: Microwave pre-coagulation (Device)
结局指标
主要结局
To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.
时间窗: 30 days prior to surgery (Baseline) and 6 weeks post surgery
We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score)
次要结局
- Clamp Time(During the operation)
- Change in Functional Renal Volume(Within 30 days prior to operation and 6 weeks post-operation)
- Tumor Margin(During the operation and 6 weeks post-operation)
- Complication Rates(During the operation)
- Blood Loss(During the operation)
- Operative Time(During the operation)
- Change in Renal Function(Within 30 days prior to operation and 6 weeks post operation)