Cerebrospinal Fluid Leakage Clinical Trial
Official title:
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
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.
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.
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