Status:
COMPLETED
DuraSeal Sealant Post Market Study
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Elective Cranial Procedures With Dural Incision
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a po...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patient is between 18 and 75 years of age
- Patient is scheduled for an elective cranial procedure that entails a dural incision
- Evidence of intraoperative non-watertight closure
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00704340
Start Date
September 1 2005
End Date
May 1 2009
Last Update
September 7 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Confluent Surgical
Waltham, Massachusetts, United States, 02451