NCT03323021已完成不适用
A Single-Center Double Arm Single-Blinded Randomized Screening Clinical Trial to Evaluate the Use of Human Dehydrated Amnion/Chorion Membrane to Facilitate the Recovery of Renal Function Following Robotic Partial Nephrectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Recovery of Renal Function
研究概览
简要总结
After partial nephrectomy, kidney function decreases by about 10% overall and by about 20% in the operated kidney. This is primarily due to the loss of healthy parenchymal volume during resection of the tumor. In an effort to preserve and regenerate healthy parenchyma during the procedure and ultimately renal function after partial nephrectomy, the single center double arm single-blinded randomized screening clinical trial will evaluate the ability of human amnion/chorion allograft to facilitate the recovery of renal function following robotic partial nephrectomy.
详细描述
To determine whether Amniofix facilitates improved recovery of renal function at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Any individual with a diagnosis of a renal mass.
- •All Patients undergoing partial nephrectomy as their definitive treatment for their renal mass.
- •Ability to understand and the willingness to sign a written informed consent.
- •Patients with a solitary clinical T1a renal mass.
排除标准
- •Patients undergoing radical nephrectomy as their definitive treatment for their renal mass.
- •Patients with Transitional Cell Carcinoma.
- •Patients with known hereditary syndromes such Von Hippel-Lindau (VHL) syndrome, Lynch Syndrome, Birt-Hogg-Dube Syndrome.
- •Patients with metastatic disease undergoing cytoreductive nephrectomy as their definitive treatment for metastatic disease.
- •Patients with prior kidney surgery.
- •Patients with a solitary or horseshoe kidney.
- •Patients with a positive margin found during intra-operative frozen section done only when clinically indicated (i.e., macroscopic abnormality identified).
- •Patients with multiple renal masses.
- •Patients with greater than a clinical T1a renal mass.
结局指标
主要结局
Recovery of Renal Function
时间窗: 12 months
Evaluation of GlomerularFiltration Rate (GFR)
次要结局
- Cancer Control Rates(12 months)
- Preservation of Renal Parenchymal Volume(12 months)
研究者
研究点 (1)
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