Surgify2021. Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To evaluate safety of SSB
研究概览
简要总结
Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.
详细描述
Sponsored observational clinical pilot study with no control group. Aim is to get a maximum of 20 study subjects, who have disease of the spine or head requiring surgery with bone removal and who are willing to participate into this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- 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 18-70 years
排除标准
- •Previous surgery on the same area
- •Abnormalities of bone tissue
- •Vulnerable patient (such as prisoner, retarded person, person in nursing home, patient in emergency situation)
- •Allergy or hypersensitivity to medical-grade stainless steel or any of alloying components
- •Problems with blood clotting
结局指标
主要结局
To evaluate safety of SSB
时间窗: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
AE reporting
To evaluate usability of SSB
时间窗: Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.
Using video material from operations, microphone recording of the surgeon commentary during drilling and questionnaires to surgeon.
次要结局
- To evaluate effectiveness of SSB(Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week.)
- To evaluate beneficiality of SSB(Duration is from recruitment until end of the time on recovery ward, approximately 1 day to 1 week)
研究者
Nuutti Vartiainen
HUS, Töölö Hospital
Surgify Medical Oy