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

Tristan Van Doormaal, Menno Germans, Menno Germans, Mariska Sie, Bart Brouwers, Andrew Carlson, Jan Willem Dankbaar, Jorn Fierstra, Paul Depauw, Pierre Robe & Luca Regli
Objective: The Dural Sealant Patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. Design: First in human, open-label, single-arm, multicenter study with 360 days (12 months) follow up. Setting: Three large tertiary reference neurosurgical centers, 2...
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