NCT04300075撤回不适用
Clinical Performance Investigation of the CUSA Clarity Bone Tip for Cranial Skull Base Bone Removal Procedures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Effectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale
研究概览
简要总结
The aim of the Study is to investigate the clinical performance and surgeon preferences of the CUSA Clarity Bone Tip during skull base surgery with removal of bony, and other cranial calcified tissue.
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
- •Subject is at least 18 years of age
- •Subject requires a cranial skull base procedure involving removal of bone with ultrasonic aspirator
- •Subject is an appropriate candidate to receive use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery, per the study surgeon
- •Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures
排除标准
- •Subject is currently pregnant or plans to become pregnant prior to the study index surgery
- •Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation
- •Subject's surgical plan includes utilizing CUSA Clarity Bone Tip for bone removal anywhere besides the cranial skull base in an open craniotomy (e.g. transsphenoidal approach or spinal procedures).
- •Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee.
- •Intra-operative exclusion criteria :
- •Surgeon does not utilize CUSA Clarity Bone Tip for cranial skull base bone removal during surgery or utilizes CUSA Clarity Bone Tip anywhere else besides the cranial skull base
结局指标
主要结局
Effectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale
时间窗: Surgery time
Multifactorial 5-point Likert scale (1 (worst) to 5 (best))
次要结局
未报告次要终点
研究者
研究点 (6)
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