Status:
COMPLETED
Study to Evaluate Safety & Effectiveness of Spinal Sealant
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Cerebrospinal Fluid Leakage, Subdural
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
Detailed Description
Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebros...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects scheduled for a spinal procedure that requires a dural incision
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00444067
Start Date
May 1 2007
End Date
August 1 2009
Last Update
September 7 2017
Active Locations (1)
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1
Confluent Surgical, Inc.
Bedford, Massachusetts, United States, 01730