Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy

Inclusion Criteria: 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 Exclusion Criteria: 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