The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures. This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.
This is a prospective, randomized, controlled, single-blind, multicenter, pivotal trial that will evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact. Subjects who are undergoing spinal surgery, consent to participate in this trial and experience a durotomy will be considered for study enrollment. Following a two-tiered inclusion/exclusion consideration, subjects will be randomized intraoperatively using a 1:1 randomization ratio. Up to 90 subjects will be randomized to treatment with either Adherus Dural Sealant or DuraSeal Exact with at least 50% of subjects undergoing procedures at lumbar or lumbosacral levels. Up to 30 investigational sites within the United States will participate in this trial. A primary composite endpoint evaluating safety and effectiveness will be measured within a 90-day required follow-up period post-procedure. Subjects will be followed at discharge or between postoperative days (POD) 1-4 from the index procedure (whichever occurs first) and at 30 days and 90 days post-index procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
Adherus Dural Sealant, In situ polymerizing sealant
DuraSeal Exact (P080013b)
City of Hope National Medical Center
Duarte, California, United States
University of California Davis Health
Sacramento, California, United States
Stanford University
The proportion of treated subjects who are free from the following incidences:
* CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 90-day follow-up period following the index procedure * Unplanned retreatment of the original surgical site adjudicated by the Clinical Events Committee (CEC) to be device-related, other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 90-day follow-up period including: * treatment for deep infection * treatment for meningitis * minimally invasive procedures or return to the operating room for neurosurgical complications
Time frame: 90 Days
Secondary endpoints, which will only be tested for superiority of Adherus over DuraSeal Exact after the primary objective of the study has been met:
* CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 30-day and 90-day follow-up period following the index procedure * Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 30-day and 90-day follow-up period including: * treatment for deep infection * treatment for meningitis * minimally invasive procedures or return to the operating room for neurosurgical complications
Time frame: 30 Day, 90 Day
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Stanford, California, United States
Mayo Clinic (FL)
Jacksonville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Columbia University Irving Medical Center
New York, New York, United States
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
...and 4 more locations