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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: November 25, 2016
Last verified: November 2016
  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
Cerebrospinal Fluid Leakage
Device: I-020805

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

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

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: November 25, 2016
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Cerebrospinal Fluid Leak
Cerebrospinal Fluid Rhinorrhea
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2017