Single-arm, open-label, multicenter study to evaluate the safety and performance of Dura Sealant Patch in reducing CSF leakage following elective cranial surgery - ENCASE

Polyganics BV, Groningen0 个研究点目标入组 31 人开始时间: 待定最近更新: 2024年4月15日

试验速览

Trial is onging in other countries

•Preoperative; Subjects who are able to provide a written informed consent prior to participating in the clinical investigation. Subjects who are * 18 years old. Subjects who are able to comply with the followup or other study requirements. Subjects who are planned for an elective intracranial intradural surgery in whom a dural incision of at least 2 cm in length is necessary, which will be closed. Female subjects of child bearing potential must agree to use any form of contraception from the time of signing the informed consent form through 90 days post-surgery. Intraoperative;
•Surgical wound classification Class I/Clean. Minimally 5 mm of dural space surrounding dural opening.

•Preoperative; Female subjects who are pregnant or breastfeeding. Subjects with an assumed impaired coagulation due to medication or otherwise. Subjects suspected of an infection requiring antibiotics. Subjects with any type of dural diseases in planned dural closure area. Subjects requiring re-opening of planned surgical area within 90 days after surgery. Subjects requiring local radiotherapy in planned surgical area. Subjects with a known allergy to any of the components of the Dura Sealant Patch. Subject who previously participated in this study or any investigational drug or device study within 30 days of screening. Subjects with a presence of hydrocephalus. Subjects with contra-indication to MRI. Intraoperative; Subjects in whom elevation of PEEP or pCO2 has a potential detrimental effect. Subjects who will require a CSF or wound drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery. Primary closure of the dura mater with synthetic, non-autologous or autologous material other than galea. A gap > 3 mm after primary closure of the dura mater.

发起方

Polyganics BV, Groningen