A Pilot Feasibility Study for Cerebral Open Flow Microperfusion in Patients Undergoing Planned Neurosurgical Resection of Diseased Parenchyma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •ECOG performance status (PS) 0, 1 or
- •Clinical and radiographic evidence diagnosis of glioma, or a prior diagnosis of glioma (suspected WHO grade II-IV), OR clinical evidence of epileptic foci requiring a temporal lobectomy.
- •Clinical indication for resection as part of routine clinical care, with plan for this to be performed at Mayo Clinic (Rochester, MN).
- •Able and willing to provide informed consent either signed by themselves or a legally authorized representative.
排除标准
- •Vulnerable populations: pregnant women, prisoners or the mentally handicapped.
- •Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
- •Patients whom the surgeon deems to be at increased risk of adverse effects from the study.
研究组 & 干预措施
Study Group
Patients undergoing a planned neurosurgical resection of diseased brain parenchyma.
干预措施: Cerebral open flow microperfusion (Device)
结局指标
主要结局
Adverse events
时间窗: 1 year
Number of patients who develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of microperfusate catheters. Adverse events will be measured by CTCAE 5.0.
Sample collection
时间窗: 1 year
Number of patients for whom at least 1 specimen containing \> 10 μL microperfusate is successfully collected from 2 or more locations.
次要结局
未报告次要终点