NCT01295619已完成不适用
A Prospective, Open, Multi-center, Single-arm Study of the Performance and Safety of I-020805 in the Prevention of Cerebrospinal Fluid Leakage Following Elective Cranial Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 8
- 主要终点
- Performance of I-020805 in prevention of CSF leakage
研究概览
简要总结
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
详细描述
Patients who consented to participate in the trial and fulfilled the preoperative inclusion and exclusion criteria underwent screening prior to surgical treatment. After dural suturing, if patients met the intra operative inclusion and exclusion criteria, they received I-020805. If necessary, autologous grafts were to be used to augment dural closure.
I-020805 was delivered from a double syringe applicator that creates a fine layer over the dura. This layer quickly sets within seconds to form a watertight seal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Pre-operative
- •Male or female of 18 years old or over
- •Elective cranial procedure entailing a dural incision of at least 2 cm in length
- •Requires a procedure involving surgical wound classification Class I/Clean
- •Signed informed consent form
- •Negative pregnancy test at screening for women of childbearing potential and agreeing to use an acceptable birth control method or abstinence until 90 days post-surgery
- •Intra-operative
- •Surgical wound classification Class I/Clean
- •Dural margin from bony edges of at least 3 mm throughout
- •Spontaneous expression of CSF assessed visually or a CSF leakage upon Valsalva maneuver
排除标准
- •Pre-operative
- •Cranial procedure requiring translabyrinthine, transoral and/or any procedure penetrating the air sinus or mastoid air cells
- •Presence of symptomatic hydrocephalus
- •Pre-existing external ventricular drainage or lumbar CSF drain
- •Radiotherapy in the planned surgical region which ended within 3 months prior to planned surgery
- •Presence of systemic infection
- •Known history of hemophilia or other clinically significant coagulopathy
- •Known oral anticoagulant use
- •Pregnancy or breast feeding
- •Known allergy to any components of I-020805
- •Previous participation in this trial or any investigational drug or device study within 30 day of screening
- •Known clinically significant organ or systemic diseases
- •Known or suspected non-compliance with trial procedures
- •Intra-operative
- •Patient not meeting the pre-operative eligibility criteria
- •Not able to tolerate a Valsalva maneuver
- •Gap of more than 2 mm remaining after primary closure of dura
- •Use of synthetic or non-autologous duraplasty material
结局指标
主要结局
Performance of I-020805 in prevention of CSF leakage
时间窗: Intraoperative on the day of sugery
次要结局
- Wound healing impairment(Throughout study up to 90 days following surgery)
- Incidence of CSF leakage(Within 7 days after surgery or prior to discharge)
- CSF leakage or pseudomeningocele related surgical intervention(Within 90 days following surgery)
- CSF leakage confirmed by clinical evaluation or diagnostic testing(Within 90 days following surgery)
- Surgical infection and unexpected neurological signs(Post-operative and within 7 days and 90 following surgery)
- Incidence of all and treatment emergent adverse events(Throughout study up to 90 days following surgery)
研究者
研究点 (8)
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