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Title: A Pivotal Clinical Trial Examining the Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures      
available:
True
dateReleased:
07-06-2010
description:
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.
privacy:
information not available
aggregation:
instance of dataset
ID:
NCT01158378
refinement:
curated
keywords:
Adherus Dural Sealant
Adherus AutoSpray Dural Sealant
dateModified:
02-26-2014
availability:
available
types:
clinical trial
name:
Elective Cranial Procedures With Dural Incision
name:
Device
agent:
Adherus Dural Sealant
schedulesActivity:
In situ polymerizing sealant
funders:
HyperBranch Medical Technology, Inc
selectionCriteria:
Inclusion Criteria: - 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 Criteria: - 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.
studyGroups:
DuraSeal Dural Sealant System
Adherus Dural Sealant System
types:
Interventional
ID:
HBMT-080453
accessURL: https://clinicaltrials.gov/ct2/show/results/NCT01158378
storedIn:
ClinicalTrial.gov
format:
HTML
accesstypes:
landing page
dateVerified:
20140201
authentication:
none
authorization:
none
creators:
HyperBranch Medical Technology, Inc
homepage: https://clinicaltrials.gov
ID:
SCR:002309
name:
ClinicalTrials.gov

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