Status:
COMPLETED
DuraSeal Exact Spine Sealant System Post-Approval Study
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Dural Sealing
Eligibility:
All Genders
18+ years
Brief Summary
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 Spi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
924 Patients enrolled
Trial Details
Trial ID
NCT01410864
Start Date
August 1 2011
End Date
July 1 2016
Last Update
March 1 2017
Active Locations (36)
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1
Phoenix, Arizona, United States, 85023
2
Los Angeles, California, United States, 90033
3
Sacramento, California, United States, 95616
4
San Francisco, California, United States, 94143