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

Primary Purpose

Cerebrospinal Fluid Leakage

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
I-020805
Sponsored by
Kuros Biosurgery AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebrospinal Fluid Leakage focused on measuring Dura, Sealant, Cranial, Craniotomy, CSF leakage, CSF leakage following cranial surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite Universitätsmedizin (01)
  • Orszagos Idegtudomanyi Intezet (11)
  • Debreceni Tudomanyegyetem (12)
  • Szegedi Tudomanyegyetem (10)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I-020805

Arm Description

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.

Outcomes

Primary Outcome Measures

Performance of I-020805 in prevention of CSF leakage

Secondary Outcome Measures

Incidence of CSF leakage
CSF leakage or pseudomeningocele related surgical intervention
CSF leakage confirmed by clinical evaluation or diagnostic testing
Surgical infection and unexpected neurological signs
Wound healing impairment
Incidence of all and treatment emergent adverse events

Full Information

First Posted
February 9, 2011
Last Updated
November 25, 2016
Sponsor
Kuros Biosurgery AG
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1. Study Identification

Unique Protocol Identification Number
NCT01295619
Brief Title
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuros Biosurgery AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrospinal Fluid Leakage
Keywords
Dura, Sealant, Cranial, Craniotomy, CSF leakage, CSF leakage following cranial surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I-020805
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
I-020805
Intervention Description
A thin layer of I-020805 applied up to two times on the sutured dura mater
Primary Outcome Measure Information:
Title
Performance of I-020805 in prevention of CSF leakage
Time Frame
Intraoperative on the day of sugery
Secondary Outcome Measure Information:
Title
Incidence of CSF leakage
Time Frame
Within 7 days after surgery or prior to discharge
Title
CSF leakage or pseudomeningocele related surgical intervention
Time Frame
Within 90 days following surgery
Title
CSF leakage confirmed by clinical evaluation or diagnostic testing
Time Frame
Within 90 days following surgery
Title
Surgical infection and unexpected neurological signs
Time Frame
Post-operative and within 7 days and 90 following surgery
Title
Wound healing impairment
Time Frame
Throughout study up to 90 days following surgery
Title
Incidence of all and treatment emergent adverse events
Time Frame
Throughout study up to 90 days following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Jamieson, MD
Organizational Affiliation
Kuros Biosurgery
Official's Role
Study Director
Facility Information:
Facility Name
Charite Universitätsmedizin (01)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Orszagos Idegtudomanyi Intezet (11)
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Tudomanyegyetem (12)
City
Debrecen
ZIP/Postal Code
4023
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem (10)
City
Szeged
ZIP/Postal Code
6725
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

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

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