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

Kuros Biosurgery AG4 sites in 2 countries41 target enrollmentFebruary 2011

ConditionsCerebrospinal Fluid Leakage

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebrospinal Fluid Leakage
Sponsor: Kuros Biosurgery AG
Enrollment: 41
Locations: 4
Primary Endpoint: Performance of I-020805 in prevention of CSF leakage
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

December 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Kuros Biosurgery AG

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Performance of I-020805 in prevention of CSF leakage

Time Frame: Intraoperative on the day of sugery

Secondary Outcomes

Wound healing impairment(Throughout study up to 90 days following surgery)
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)
Incidence of all and treatment emergent adverse events(Throughout study up to 90 days following surgery)