A Pilot Feasibility and Safety Study Using Robotic Assisted Surgery in Patients With Spine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Complication rates with 95% confidence bounds of +/- 31% or smaller
研究概览
简要总结
This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery
详细描述
PRIMARY OBJECTIVES:
I. To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot.
SECONDARY OBJECTIVES:
I. To compare complication rates, operative time and estimated blood loss with historical controls.
II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.
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 has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI)
- •Karnofsky performance status (PS) of >= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1
- •Expected survival greater than 3 months
- •Patient must be able to understand and sign a study-specific informed consent form
排除标准
- •Previous surgery at that specific segment
- •Radiation at that specific spinal segment within the last 2 months
- •Karnofsky PS < 80 or ECOG PS > 1
- •Pregnancy (due to risk of anesthesia)
- •The presence of medical conditions which contraindicate general anesthesia
- •Unexplained fever or untreated, active infection
- •Inability to obtain exposure to allow performance of the planned spine surgical procedure
- •History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
结局指标
主要结局
Complication rates with 95% confidence bounds of +/- 31% or smaller
时间窗: For 100 days post-surgery
Estimated blood loss
时间窗: For 100 days post-surgery
Operation duration
时间窗: At the completion of surgery
Complication rate
时间窗: For 100 days post-surgery
Demographic and clinical data such as stage, grade and histology
时间窗: At baseline
次要结局
未报告次要终点