Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
A Pivotal Clinical Trial Examining the Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
1 other identifier
interventional
250
1 country
17
Brief Summary
The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2010
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 6, 2010
CompletedFirst Posted
Study publicly available on registry
July 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
April 8, 2014
CompletedApril 8, 2014
February 1, 2014
2.6 years
July 6, 2010
February 26, 2014
February 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site
The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences: * Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds. * CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure * Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 120-day follow-up period.
120 days
Secondary Outcomes (1)
Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.
120 days
Study Arms (2)
DuraSeal Dural Sealant System
ACTIVE COMPARATORAdherus Dural Sealant System
EXPERIMENTALInterventions
In situ polymerizing sealant
Eligibility Criteria
You may qualify if:
- Subject is scheduled for an elective cranial procedure involving a dural incision using any of the following surgical locations/approaches (or combination): frontal, temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class 1/clean wound (uninfected surgical wound in which no inflammation is encountered)
- Subject's linear extent of durotomy is ≥2 cm
- Subject's dural margins from the edges of bony defect are ≥3 mm throughout
- Subject's CSF leak is present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva maneuver, at up to 20 cm H2O for up to five (5) seconds
You may not qualify if:
- Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-peritoneal shunts.
- Subject has an external ventricular or lumbar CSF drain that must be left in place after surgery.
- Subject has a systemic infection or evidence of any infection near planned operative site.
- Subject requires the intra-operative placement of a CSF diversion device (e.g. ventricular catheter, subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that will be left in place after the procedure. Note: Subgaleal drains used for acute post-operative management of the incision site are permitted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Colorado Brain and Spine Institute/Swedish Medical Center
Englewood, Colorado, 80113, United States
Florida Hospital
Orlando, Florida, 32804, United States
University of South Florida
Tampa, Florida, 33606, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Wayne State University
Detroit, Michigan, 48201, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794-8122, United States
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157-1029, United States
Mayfield Clinic
Cincinnati, Ohio, 45219, United States
Oklahoma Spine and Brain Institute
Tulsa, Oklahoma, 74132, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
West Virginia University
Morgantown, West Virginia, 26506-9183, United States
Related Publications (1)
Bakar B, Kose EA, Balci M, Atasoy P, Sarkarati B, Alhan A, Kilinc K, Keskil IS. Evaluation of the neurotoxicity of the polyethylene glycol hydrogel dural sealant. Turk Neurosurg. 2013;23(1):16-24. doi: 10.5137/1019-5149.JTN.6039-12.1.
PMID: 23344862BACKGROUND
Results Point of Contact
- Title
- Michael Carnahan, PhD
- Organization
- HyperBranch Medical Technology, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Smith, MD
Carolina Neurosurgery & Spine Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2010
First Posted
July 8, 2010
Study Start
June 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
April 8, 2014
Results First Posted
April 8, 2014
Record last verified: 2014-02