NCT04859907已完成不适用
Bone Flap Fixation Systems For Craniotomy Procedures
NEOS Surgery3 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2021年3月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Bone flap alignment score
研究概览
简要总结
Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •The subject is 18 years or older.
- •The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use.
- •At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed.
- •Life expectancy higher than 6 months.
- •The subject is willing to give his/her informed consent and to comply with the required follow-up.
排除标准
- •The subject presents any of the contraindications of the assigned craniotomy closure system.
- •Orbitozygomatic or mastoid craniotomies.
- •Posterior fossa (skull base) surgeries.
- •Combined used of craniotomy systems (plates and clamps).
- •The subject is currently participating in an investigational drug or device study.
研究组 & 干预措施
Clamp-like system
Experimental
干预措施: Clamp-like system (Device)
Plates and screws
Active Comparator
干预措施: Plates and screws (Device)
结局指标
主要结局
Bone flap alignment score
时间窗: 6 months
1-4
次要结局
- Frequency of adverse effects and device deficiencies (device safety)(6 months)
- Surgeon usability questionnaire(0 days after surgery)
- Device-related bulges or visible offsets(6 months)
- Post-craniotomy headache(6 months)
- Device related artefacts in neuroimaging(6 months)
- Bone-flap alignment score(0-7 days after surgery (before discharge))
研究者
研究点 (3)
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