Cook® iMRI Needles Non-Significant Risk Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary Performance Outcome
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the Cook® iMRI Needle. This is an investigational needle that physicians can use to gain access to a particular part of the body, take a small sample of tissue, or inject fluid into a particular part of the body.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is suitable for inclusion in the study if the patient meets the following criteria:
- •A qualified physician directs the patient to have a procedure that requires a needle
- •for percutaneous access, aspiration, and/or injection during therapeutic or diagnostic interventional MRI-guided procedures
- •Patients, or their legally authorized representatives, must also voluntarily consent to participate in the study
排除标准
- •Inability or refusal to give informed consent by the patient or legally authorized representative
- •Age < 18 years
- •Vulnerable population (specifically prisoners, lactating women and/or cognitively impaired patients)
- •Patients lacking a safe trajectory to the target tissue, as determined by the physician
- •Patients with uncorrectable coagulopathy
- •Allergy to the device or contrast media that cannot be adequately premedicated
- •Body habitus or medical condition that compromises or prevents necessary imaging procedures
- •Body weight exceeding limits of available MRI machines
- •Target lesion is unable to be reached by the longest needle (or in combination with a core biopsy device)
- •Implanted non-MR conditional device or other metallic device (e.g., certain pacemakers, aneurysm clips, cochlear implants, and/or mechanical heart valves)
- •Inability of the patient to cooperate with, or to be positioned for, the procedure
研究组 & 干预措施
Patient Cohort
干预措施: Percutaneous non-vascular access to anatomic structures (Device)
结局指标
主要结局
Primary Performance Outcome
时间窗: Duration of procedure (approximately 1 hour)
Successful percutaneous needle introduction into the target anatomy.
Successful needle introduction
时间窗: Duration of procedure (approximately 1 hour)
Successful percutaneous needle introduction into the target anatomy.
Rate of successful needle introduction
时间窗: Duration of procedure (approximately 1 hour)
Successful percutaneous needle introduction into the target anatomy.
次要结局
未报告次要终点