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

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