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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Cerebrospinal Fluid Leakage

Intervention / Treatment
-----------------
* Device: I-020805


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-020805<br>This was a prospective, open, multi-center, single-arm study to investigate I-020805 in patients following elective cranial surgery. If they met the inclusion/ exclusion criteria, they receive I-020805 after suturing of the dura. If necessary, autologous grafts were to be used to augment dural closure. | Device: I-020805<br>* A thin layer of I-020805 applied up to two times on the sutured dura mater<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of I-020805 in prevention of CSF leakage |  | Intraoperative on the day of sugery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CSF leakage |  | Within 7 days after surgery or prior to discharge | 
| CSF leakage or pseudomeningocele related surgical intervention |  | Within 90 days following surgery | 
| CSF leakage confirmed by clinical evaluation or diagnostic testing |  | Within 90 days following surgery | 
| Surgical infection and unexpected neurological signs |  | Post-operative and within 7 days and 90 following surgery | 
| Wound healing impairment |  | Throughout study up to 90 days following surgery | 
| Incidence of all and treatment emergent adverse events |  | Throughout study up to 90 days following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dura, Sealant, Cranial, Craniotomy, CSF leakage, CSF leakage following cranial surgery