NL-OMON52748已完成不适用
Randomized, two-arm, multicenter study to evaluate the safety and efficacy of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery - ENCASE II
Polyganics BV, Groningen0 个研究点目标入组 26 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Preoperative
- •1. Subjects who are able to provide written informed consent prior to
- •participating in the clinical investigation.
- •2. Subjects who are >= 22 years old.
- •3. Subjects who are able to comply with the follow-up or other study
- •requirements.
- •4. Subjects wo are planned for elective surgery including a trepanation to
- •reach the subdural infratentorial space (with lower limit of incision defined
- •as the lower edge of C2) in whom a dural incision will be closed.
- •5. Female subjects of child bearing potential must agree to use a form of
- •contraception from the time of signing the informed consent form through 90
- •days post-surgery.
- •Intraoperative
- •1. Subjects with surgical wound classification Class I/Clean.
- •2. Subjects with minimally 5 mm of dural space surrounding dural opening.
排除标准
- •Preoperative
- •1. Female subjects who are pregnant or breastfeeding.
- •2. Subjects with an assumed impaired coagulation due to medication or otherwise.
- •3. Subjects with presence of an infection.
- •4. Subjects with any type of dural diseases in planned dural closure area.
- •5. Subjects requiring re-opening of planned surgical area within 90 days after
- •6. Subjects with a known allergy to any of the components of LIQOSEAL®
- •(Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane;
- •Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C
- •Green No 6), DuraSeal and Adherus.
- •7. Subjects who previously received a LIQOSEAL®, DuraSeal or Adherus.
- •8. Subjects who previously participated in this study or any investigational
- •drug or device study within 30 days of screening.
- •9. Subjects with a presence of hydrocephalus.
- •10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator,
- •severe claustrophobia, injured by a metallic object that was not removed,
- •cochlear (ear) implants, metallic implants [e.g. knee replacement].
- •Intraoperative
- •1. Subjects in whom elevation of PEEP has a potential detrimental effect.
- •2. Subjects who will require a CSF drain, electrodes or other devices passing
- •the dural layer or extra to intracranial bypass surgery.
- •3. Subjects who have primary closure of the dura mater with non-autologous
- •4. Subjects in whom no intra-operative CSF leakage is present after primary
- •closure of the dura mater with elevation of PEEP.
- •5. Subjects who after primary closure (including galea, if applicable) of the
- •dura mater have a gap > 3 mm.
- •6. Subjects whose dural opening size including
- •5 mm margin exceeds patch size (8 x 8 cm).
研究者
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