Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Brainlab AG
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Diagnostic yield
研究概览
简要总结
This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial. The goal is to determine whether the robotic procedure to be examined can achieve a clinically acceptable value of at least 90% in terms of diagnostic yield.
详细描述
The goals of the project are to determine the accuracy of Cirq® Robotic Alignment Module Cranial navigated biopsy procedures, Automatic Image Registration accuracy within the workflow, and compatibility of Cirq® Robotic Alignment Module Cranial in the clinical workflow. Patients will undergo cranial biopsies according to standard of care using released products within their intended use with the exception that the accuracy of the biopsy needle will be measured using a specific intraoperative workflow.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff
- •Ability to consent to the procedure
排除标准
- •Pregnancy
- •Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent
结局指标
主要结局
Diagnostic yield
时间窗: 24 months
Determine the percentage of diagnostically significant biopsies determined histologically
次要结局
- Time for procedure(24 months)
- Target point and entry point error(24 months)