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

NCT ID: NCT01295619

Last Updated: 2016-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-12-31

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.

Conditions

Cerebrospinal Fluid Leakage

Keywords

Dura; Sealant; Cranial; Craniotomy; CSF leakage; CSF leakage following cranial surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

I-020805

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.

Group Type: EXPERIMENTAL

I-020805

Intervention Type: DEVICE

A thin layer of I-020805 applied up to two times on the sutured dura mater

Interventions

I-020805

A thin layer of I-020805 applied up to two times on the sutured dura mater

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuros Biosurgery AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia Jamieson, MD

Role: STUDY_DIRECTOR

Kuros Biosurgery

Locations

Charite Universitätsmedizin (01)

Berlin, , Germany

Orszagos Idegtudomanyi Intezet (11)

Budapest, , Hungary

Debreceni Tudomanyegyetem (12)

Debrecen, , Hungary

Szegedi Tudomanyegyetem (10)

Szeged, , Hungary

Countries

Germany; Hungary

Other Identifiers

CS I-020805/01

Identifier Type: -

Identifier Source: org_study_id