Status:
COMPLETED
Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
Lead Sponsor:
HyperBranch Medical Technology, Inc
Conditions:
Elective Cranial Procedures With Dural Incision
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Detailed Description
After surgery on the head, the dura, a membrane that covers the brain, must be closed in order to prevent CSF from leaking outside of the dura. When CSF leaks outside the dura, this can increase the r...
Eligibility Criteria
Inclusion
- Pre-Operative Inclusion Criteria
- 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)
- Intra-Operative Inclusion Criteria
- 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
Exclusion
- Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells are appropriately sealed (e.g. bone wax).
- 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 had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure is not an exclusion criterion).
- Subject has a systemic infection or evidence of any infection near planned operative site.
- Intra-Operative Exclusion Criteria
- Subject has an Incidental finding that meets any pre-operative exclusion criterion listed above.
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01158378
Start Date
June 1 2010
End Date
January 1 2013
Last Update
April 8 2014
Active Locations (17)
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1
Colorado Brain and Spine Institute/Swedish Medical Center
Englewood, Colorado, United States, 80113
2
Florida Hospital
Orlando, Florida, United States, 32804
3
University of South Florida
Tampa, Florida, United States, 33606
4
Northwestern University
Chicago, Illinois, United States, 60611