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临床试验/NCT04712552
NCT04712552已完成不适用

In Vivo Measurement of the Accuracy of the "Neurolocate" Module of the Neurosurgical Robot "Neuromate" in Its Application to Deep Brain Stimulation

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Euclidean distance between the point theoretically aimed at by the robot and the point actually reached

研究概览

简要总结

The purpose of this study is to evaluate the accuracy of the Neurolocate recording system of the neurosurgical robot Neuromate, marketed by Renishaw, in order to optimize surgical procedures, costs and patient comfort.

详细描述

Robotic neurosurgery has been developed for nearly 25 years and offers neurosurgeons many advantages, including increased precision.

Accuracy is a key point for stereotactic neurosurgical procedures, particularly for deep brain stimulation electrode implantations.

The accuracy of the Neuromate robot was measured in stereotactic framed and frameless mode in vitro and in vivo during stereo-electroencephalography procedures. Investigators also evaluated the actual accuracy of its application in routine deep brain stimulation procedures using a measurement system independent of the robot itself and the manufacturer. We showed that the average in vivo accuracy was 0.86 mm and the maximum error was 1.55 mm. This accuracy is at least similar to the accuracy of stereotactic frame arms and is compatible with the accuracy required in deep brain stimulation procedures.

The Neurolocate device is a new non-invasive, frameless patient matching module designed for use with the Neuromate stereotactic robot.

The main advantages of the Neurolocate system are that it is less invasive than screw-on markers, simplifies the surgical procedure and reduces the duration of the surgery The accuracy of the Neurolocate frameless recording system was evaluated in vitro and in vivo for robotic stereo-electroencephalography trajectories in epileptic patients and compared to the accuracy of conventional recording using a stereotactic frame.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 70 years old requiring a stereotactic robot-guided deep brain stimulation procedure
  • Signature of the Informed Consent Form
  • Affiliation to the French social security system

排除标准

  • Contraindication to MRI
  • Hypersensitivity to gadoteric acid, meglumine or any product containing gadolinium.
  • Anterior and posterior commissure anatomy modifying brain anatomy
  • Patient unable to complete the Comfort Questionnaire due to cognitive or speech impairment
  • Pregnant or breastfeeding women

结局指标

主要结局

Euclidean distance between the point theoretically aimed at by the robot and the point actually reached

时间窗: Day of intervention

Precision measurement: Comparison of the Euclidean distance between the point theoretically aimed at by the robot and the point actually reached, based on their respective stereotactic coordinates with respect to the anterior and posterior commissure line

次要结局

  • Occupancy time of the operating room(Day of intervention)
  • comfort of the patient(Within 3 days after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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