An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Usability and performance of the medical device Surgify Halo ™ in revision spine surgery
研究概览
简要总结
The purpose of this research study is to:
test the usability and performance of the medical device Surgify Halo ™ in revision spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).
This medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.
The target is to enroll 30 participants in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease of the spine or head requiring surgery with bone removal
- •Ability to understand the purpose and risks of the study and to give written informed consent
- •Age 21-85 years
排除标准
- •Previous surgery in the same area
- •Abnormalities of bone tissue
- •Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women
- •Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
- •Problems with blood clotting
研究组 & 干预措施
Surgify Halo
干预措施: A burr used in spine surgery (Device)
State of art Rosen burr
干预措施: A burr used in spine surgery (Device)
结局指标
主要结局
Usability and performance of the medical device Surgify Halo ™ in revision spine surgery
时间窗: From enrollment to the end of the surgery until the end of the stay in the recovery room.
Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Halo™ in comparison to the usual drill bit used in spine surgery ( Rosen burr)
次要结局
未报告次要终点