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

NCT01295619 | Completed

• 1 other identifier: CS I-020805/01
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 4

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.

Conditions

Cerebrospinal Fluid Leakage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Performance of I-020805 in prevention of CSF leakage

  Intraoperative on the day of sugery

Secondary Outcomes (6)

• Incidence of CSF leakage

  Within 7 days after surgery or prior to discharge

• CSF leakage or pseudomeningocele related surgical intervention

  Within 90 days following surgery

• CSF leakage confirmed by clinical evaluation or diagnostic testing

  Within 90 days following surgery

• Surgical infection and unexpected neurological signs

  Post-operative and within 7 days and 90 following surgery

• Wound healing impairment

  Throughout study up to 90 days following surgery

Study Arms (1)

I-020805

EXPERIMENTAL

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

Interventions

I-020805 DEVICE

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

I-020805

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuros Biosurgery AG: lead

Study Sites (4)

Charite Universitätsmedizin (01)

Berlin, 13353, Germany

Location

Orszagos Idegtudomanyi Intezet (11)

Budapest, 1145, Hungary

Location

Debreceni Tudomanyegyetem (12)

Debrecen, 4023, Hungary

Location

Szegedi Tudomanyegyetem (10)

Szeged, 6725, Hungary

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak; Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Rhinorrhea; Signs and Symptoms, Respiratory

Study Officials

• Virginia Jamieson, MD

  Kuros Biosurgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 14, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 28, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3); DE (1)