Multicentre, Prospective, Post-Market, Observational Registry Study to Observe the Performance and Safety of the Immiseal™ Dural Sealant System for Use as an Adjunct to Standard Methods of Dural Repair to Provide Watertight Closure During Neurosurgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Rate of Central Nervous System (CNS) Infection
研究概览
简要总结
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures. Eligible adult subjects requiring dural repair after neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the device, will be enrolled and followed for approximately 100 ± 10 days after surgery.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years old, regardless of gender.
- •Patients diagnosed with craniocerebral trauma, brain tumour, cerebrovascular disease, congenital disease of the nervous system, or spinal canal disease, who undergo neurosurgical procedures such as posterior fossa surgery or other interventions resulting in dural defects, whether due to surgery or accidental injury, and who present with, or are at risk of, cerebrospinal fluid (CSF) leakage requiring auxiliary dural repair.
- •Patients willing to comply with the requirements of the clinical investigation by signing the informed consent.
- •Female patients of childbearing potential must use highly effective contraceptive methods for the duration of the study. Highly effective contraceptive methods include hormonal contraception, intrauterine device, or sexual abstinence.
排除标准
- •Immiseal™ Dural Sealant System is not to be used in confined bone structures where nerves are present, since neural compression may result due to hydrogel swelling.
- •Patients with an active infection present at the surgical site.
- •Patients with life expectancy less than 3 months.
- •Female patients who are pregnant, planning pregnancy, breastfeeding, and/or unwilling to use adequate contraception during the trial.
研究组 & 干预措施
Patients Receiving Immiseal™ Dural Sealant System
Adult patients requiring dural repair following neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the Immiseal™ Dural Sealant System as an adjunct to standard methods of dural repair. Subjects will be followed for safety and device performance outcomes through approximately 100 ± 10 days post-operation.
结局指标
主要结局
Rate of Central Nervous System (CNS) Infection
时间窗: Up to 30 days post-operation
Percentage of subjects with central nervous system infection up to 30 days post-operation, including bacterial meningitis, aseptic meningitis, and/or surgical site infection.
次要结局
- Cerebrospinal Fluid (CSF) Leak Rate(Up to 100 ± 10 days post-operation)