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NCT00387829 · ClinicalTrials.gov registry record · NA
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
A NA study, sponsored by Integra LifeSciences Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 347
- Enrollment target
NCT00387829: Clinical Trial NA study, sponsored by Integra LifeSciences Corporation.
NCT00387829 is a NA study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 347 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00387829, a NA study, was terminated before completion, sponsored by Integra LifeSciences Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 347 participants
- Enrollment target
Study Summary
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.
Primary Outcome
Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage). Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain. Functional outcome score (ODI): U
Interventions
- DEVICE DuraGen Plus Adhesion Barrier Matrix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2006-10 |
| Est. Completion | 2011-12 |
| Phase | NA |
Why NCT00387829 stopped before completion
NCT00387829 is an interventional study that assigns participants to a tested intervention. The registered 347 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 (75% lower).
The record links to 0 conditions, and to 1 intervention - of which DuraGen Plus Adhesion Barrier Matrix is the first listed.
NCT00387829 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00387829 about?
NCT00387829 is a clinical study titled "DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery". To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group receiving standard care.
What is the current status of trial NCT00387829?
This trial is currently terminated. It is a NA study. The enrollment target is 347 participants. The study started on 2006-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00387829?
The interventions under investigation include: DuraGen Plus Adhesion Barrier Matrix (DEVICE).
Who is sponsoring clinical trial NCT00387829?
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 NCT00387829's enrollment target sits among peer trials
347 302nd of 2000 higher than 1,699 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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