DuraSeal Exact Spine Sealant System Post-Approval Study (DuraSeal PAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01410864|
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment|
|Dural Sealing||Device: DuraSeal Exact Spine Sealant System Other: Control|
|Study Type :||Observational|
|Actual Enrollment :||924 participants|
|Official Title:||DuraSeal Exact Spine Sealant System Post-Approval Study|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery.
Device: DuraSeal Exact Spine Sealant System
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
Subjects who have undergone a spinal procedure where techniques other than DuraSeal were administered for the treatment of either an intentional or incidental opening of the dura may be enrolled either prospectively or retrospectively (via medical record screening)
Devices or drugs used to seal the dura (other than DuraSeal)
- Post-operative CSF leaks [ Time Frame: 90 days post-operative ]
- Post-operative surgical site infections [ Time Frame: 90 days post-operative ]Deep surgical site infections as defined by the Center for Disease Control criteria.
- Post-operative neurological serious adverse events [ Time Frame: 90 days post-operative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410864
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