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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01295619
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : November 28, 2016
Information provided by (Responsible Party):
Kuros Biosurgery AG

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.

Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Leakage Device: I-020805 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : February 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Device: I-020805
A thin layer of I-020805 applied up to two times on the sutured dura mater

Primary Outcome Measures :
  1. Performance of I-020805 in prevention of CSF leakage [ Time Frame: Intraoperative on the day of sugery ]

Secondary Outcome Measures :
  1. Incidence of CSF leakage [ Time Frame: Within 7 days after surgery or prior to discharge ]
  2. CSF leakage or pseudomeningocele related surgical intervention [ Time Frame: Within 90 days following surgery ]
  3. CSF leakage confirmed by clinical evaluation or diagnostic testing [ Time Frame: Within 90 days following surgery ]
  4. Surgical infection and unexpected neurological signs [ Time Frame: Post-operative and within 7 days and 90 following surgery ]
  5. Wound healing impairment [ Time Frame: Throughout study up to 90 days following surgery ]
  6. Incidence of all and treatment emergent adverse events [ Time Frame: Throughout study up to 90 days following surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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


  • 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:


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01295619

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Charite Universitätsmedizin (01)
Berlin, Germany, 13353
Orszagos Idegtudomanyi Intezet (11)
Budapest, Hungary, 1145
Debreceni Tudomanyegyetem (12)
Debrecen, Hungary, 4023
Szegedi Tudomanyegyetem (10)
Szeged, Hungary, 6725
Sponsors and Collaborators
Kuros Biosurgery AG
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Study Director: Virginia Jamieson, MD Kuros Biosurgery

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Responsible Party: Kuros Biosurgery AG Identifier: NCT01295619     History of Changes
Other Study ID Numbers: CS I-020805/01
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kuros Biosurgery AG:
CSF leakage
CSF leakage following cranial surgery

Additional relevant MeSH terms:
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Cerebrospinal Fluid Leak
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries