NCT01410864已完成不适用
DuraSeal Exact Spine Sealant System Post-Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 924
- 主要终点
- Post-operative CSF leaks
研究概览
简要总结
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 18 years of age or older
- •Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:
- •DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR
- •Any other method of sealing the dura with the exception of DuraSeal™ Sealant -either spinal or cranial. (Control group ONLY)
- •Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.
- •Prospective subjects: Consent must be obtained within 24 hours of surgery stop time.
- •Retrospective subjects (Control group specific): IRB approval may be granted to individual sites to waive requirement for informed consent.
排除标准
- •The investigator determines that the subject will not be able to comply with the required follow-up visits (not required if subject is being enrolled retrospectively- control group ONLY)
- •Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)
结局指标
主要结局
Post-operative CSF leaks
时间窗: 90 days post-operative
次要结局
- Post-operative surgical site infections(90 days post-operative)
- Post-operative neurological serious adverse events(90 days post-operative)
研究者
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