DuraSeal Exact Spine Sealant System Post-Approval Study

Not Recruiting

Trial ID: NCT01410864


This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

Official Title

DuraSeal Exact Spine Sealant System Post-Approval Study

Stanford Investigator(s)


Inclusion Criteria:

* Subject is 18 years of age or older
* Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:

* DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR
* Any other method of sealing the dura with the exception of DuraSeal™ Sealant -either spinal or cranial. (Control group ONLY)
* Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.

* Prospective subjects: Consent must be obtained within 24 hours of surgery stop time.
* Retrospective subjects (Control group specific): IRB approval may be granted to individual sites to waive requirement for informed consent.

Exclusion Criteria:

* The investigator determines that the subject will not be able to comply with the required follow-up visits (not required if subject is being enrolled retrospectively- control group ONLY)
* Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)


device: DuraSeal Exact Spine Sealant System

other: Control

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305