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NCT00594035 · ClinicalTrials.gov registry record · NA
Study to Evaluate Safety and Effectiveness of Spinal Sealant
A NA study, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- NA
- Development phase
- 158
- Enrollment target
NCT00594035: Completed NA study, sponsored by Integra LifeSciences Corporation.
NCT00594035 is a NA study that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 158 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00594035, a NA study, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 158 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
Primary Outcome
Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively.
Interventions
- DEVICE Standard of care
- DEVICE Spinal Sealant System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-04 |
| Phase | NA |
What the finished NCT00594035 record still lists
NCT00594035 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT00594035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00594035 about?
NCT00594035 is a clinical study titled "Study to Evaluate Safety and Effectiveness of Spinal Sealant". To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.
What is the current status of trial NCT00594035?
This trial is currently completed. It is a NA study. The enrollment target is 158 participants. The study started on 2005-09. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00594035?
The interventions under investigation include: Standard of care (DEVICE), Spinal Sealant System (DEVICE).
Who is sponsoring clinical trial NCT00594035?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00594035's enrollment target sits among peer trials
158 654th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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