Trials / Completed
CompletedNCT01410864
DuraSeal Exact Spine Sealant System Post-Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 924 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 Spine Sealant System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DuraSeal Exact Spine Sealant System | DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening. |
| OTHER | Control | Devices or drugs used to seal the dura (other than DuraSeal) |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2011-08-05
- Last updated
- 2017-03-01
Locations
36 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01410864. Inclusion in this directory is not an endorsement.