NCT02291939已完成不适用
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery
Domain Surgical, Inc.1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
研究概览
简要总结
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.
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
- •Patients with an indication for surgical intervention for a parotidectomy.
- •ECOG status ≤
- •Life expectancy > 3 months.
- •Age ≥ 18 years old.
- •Able to provide written informed consent and EU Data Protection Directive forms prior to admission to this study.
- •Willingness to meet all of the expected requirements of this clinical protocol.
排除标准
- •Age < 18 years old.
- •Pregnant or breastfeeding.
- •Vulnerable patient populations (homeless patients, patients with drug or alcohol dependence, etc.).
- •Concomitant treatments that would affect clotting, post-operative healing, increased chances of infection.
- •Previous radiation treatment
- •Previous head or neck surgery
结局指标
主要结局
Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility
时间窗: 1 day after surgery
Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System.
次要结局
- Post-operative drainiage(Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days)
- Necrosis of surgical margins(Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days)
- Swelling of surgical wound(Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days)
- Length of hospital stay(Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days)
研究者
研究点 (1)
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