NCT07140731招募中不适用
An Early Feasibility Study for the Symani Surgical System
Jacobs institute2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年9月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- CT Imaging
研究概览
简要总结
A research study for a neurosurgical procedure in adult patients with Moyamoya disease
详细描述
The purpose of this research is to assess the safety and effectiveness of the Symani Surgical System in adult patients with Moyamoya disease.
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
- •Patients aged >
- •Moyamoya disease with minor to moderate symptoms requiring neurosurgical treatment.
- •Patients agree to have the surgery and the anesthesia.
- •Patients who voluntarily decide to participate in this study with the surgery performed with the aid of Symani and agree to sign the Informed Consent Form.
排除标准
- •Patients who have bleeding or coagulation disorders in the past or present.
- •Any criteria that preclude prolonged anesthesia.
- •Hemodynamically unstable neurological exam.
- •Pressure dependent neurologic status.
结局指标
主要结局
CT Imaging
时间窗: 6 Months
Stable cerebral perfusion confirmed with CT Imaging
次要结局
未报告次要终点
研究者
Adnan Siddiqui
Principal Investigator
Jacobs institute
研究点 (2)
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