Clinical trial
Study to Evaluate Safety & Effectiveness of Spinal Sealant
NCT00444067 · Integra LifeSciences Corporation, Industry · Completed
Key facts
| NCT number | NCT00444067 |
|---|---|
| Title | Study to Evaluate Safety & Effectiveness of Spinal Sealant |
| Official title | A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery |
| Lead sponsor | Integra LifeSciences Corporation, Industry |
| Collaborators | Medtronic - MITG Industry |
| Status | Completed |
| Study type | Interventional |
| Conditions | Cerebrospinal Fluid Leakage, Subdural |
| Intervention type | Device, Other |
| Interventions | Spinal Sealant, Standard of Care |
| Enrollment | 98 |
| Start date | May 1, 2007 |
| Primary completion | Aug 1, 2009 |
| Completion | Aug 1, 2009 |
| First posted | Mar 7, 2007 |
| Last update posted | Sep 7, 2017 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: