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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuros Biosurgery AG
ClinicalTrials.gov Identifier:
NCT01295619
First received: February 9, 2011
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Cerebrospinal Fluid Leakage
 Device: Dural sealant
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Kuros Biosurgery AG:

Primary Outcome Measures:
  • Performance of I-020805 in prevention of CSF leakage [ Time Frame: Intraoperative on the day of sugery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of CSF leakage [ Time Frame: Within 7 days after surgery or prior to discharge ] [ Designated as safety issue: No ]
  • CSF leakage or pseudomeningocele related surgical intervention [ Time Frame: Within 90 days following surgery ] [ Designated as safety issue: No ]
  • CSF leakage confirmed by clinical evaluation or diagnostic testing [ Time Frame: Within 90 days following surgery ] [ Designated as safety issue: No ]
  • Surgical infection and unexpected neurological signs [ Time Frame: Post-operative and within 7 days and 90 following surgery ] [ Designated as safety issue: Yes ]
  • Wound healing impairment [ Time Frame: Throughout study up to 90 days following surgery ] [ Designated as safety issue: Yes ]
  • Incidence of all and treatment emergent adverse events [ Time Frame: Throughout study up to 90 days following surgery ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I-020805 Device: Dural sealant
A thin layer of I-020805 applied up to two times on the sutured dura mater

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295619

Locations
Germany
Charite Universitätsmedizin (01)
Berlin, Germany, 13353
Hungary
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
Investigators
Study Director: Virginia Jamieson, MD Kuros Biosurgery
  More Information

No publications provided

Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT01295619     History of Changes
Other Study ID Numbers: CS I-020805/01
Study First Received: February 9, 2011
Last Updated: March 15, 2012
Health Authority: Hungary: Office of Health Authorization and Administrative Procedures - Department for Medical Devices
Hungary: Scientific and Medical Research Council Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by Kuros Biosurgery AG:
Dura
Sealant
Cranial
 Craniotomy
CSF leakage
CSF leakage following cranial surgery

Additional relevant MeSH terms:
Cerebrospinal Fluid Rhinorrhea
Intracranial Hypotension
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
 Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013