A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment With Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath™ RC120 Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RenovoRx
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Survival
研究概览
简要总结
This is an observational study to assess patient survival and clinical outcomes after the RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.
详细描述
This is an observational, registry study to assess patient survival and clinical outcomes of the RenovoCath™ RC120 catheter when used to deliver chemotherapeutic agents to pancreatic tumors. Blood samples will be drawn in a subset of patients to assess the systemic concentration of the chemotherapeutic agent.
The RenovoCath™ RC120 Catheter is an endovascular multi-lumen, two-handled catheter designed to isolate variable segments of arteries supplying the target organ using two slideable, compliant balloons. Upon inflation of the proximal occlusion balloon and the distal occlusion balloon, the catheter may isolate the selected site to specifically deliver radiopaque and therapeutic agents including, but not limited to chemotherapeutic drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years of age
- •Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology
- •Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure
- •Willing to provide informed consent and comply with the required follow-up.
排除标准
- •Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment.
- •Currently participating in another active drug or device study or registry protocol that would interfere with this study.
- •Vulnerable populations: prisoners, pregnant or breastfeeding females.
结局指标
主要结局
Survival
时间窗: 2 Years
Duration of survival in patients diagnosed with pancreatic cancer who undergo intra-arterial delivery of chemotherapeutic agents to the pancreas
次要结局
- Tumor response(6 months)