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NCT00859508 · ClinicalTrials.gov registry record · NA
Study of SyntheCelTM Dura Replacement to Other Dura Replacements
A NA study of Cranial Dura Repair, sponsored by Synthes USA HQ.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
- 8
- Study locations
NCT00859508: Completed NA study of Cranial Dura Repair, sponsored by Synthes USA HQ.
NCT00859508 is a NA study of Cranial Dura Repair that has completed, run by Synthes USA HQ. The registered enrollment target is 99 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00859508, a NA study of Cranial Dura Repair, has completed, sponsored by Synthes USA HQ.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
- 8
- Study locations
Study Summary
Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.
Primary Outcome
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
Conditions Studied
Interventions
- DEVICE SyntheCel
- DEVICE Other FDA cleared dura replacements
Study Locations (8)
Arizona
- Barrow Neurosurgical Institute - Scottsdale
California
- Stanford Medical Center - Stanford
Florida
- University of Florida - Gainesville
Oregon
- Oregon Health Sciences University - Portland
Pennsylvania
- Allegheny General Hospital - Pittsburgh
Texas
- University of Texas - Houston
Virginia
- University of Virginia - Charlottesville
West Virginia
- West Virginia University School of Medicine - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-01 |
| Phase | NA |
What the finished NCT00859508 record still lists
NCT00859508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Cranial Dura Repair appearing as the primary indexed condition, and to 2 interventions - of which SyntheCel is the first listed.
NCT00859508 lists 8 locations in 8 states (Arizona, California, Florida).
Frequently Asked Questions
What is clinical trial NCT00859508 about?
NCT00859508 is a clinical study titled "Study of SyntheCelTM Dura Replacement to Other Dura Replacements". Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.
What is the current status of trial NCT00859508?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2006-02. Estimated completion is 2009-01.
What conditions does trial NCT00859508 study?
This clinical trial studies the following conditions: Cranial Dura Repair.
What interventions are being tested in trial NCT00859508?
The interventions under investigation include: SyntheCel (DEVICE), Other FDA cleared dura replacements (DEVICE).
Who is sponsoring clinical trial NCT00859508?
This trial is sponsored by Synthes USA HQ, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00859508 being conducted?
This trial has 8 study locations across Arizona, California, Florida, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00859508's enrollment target sits among peer trials
99 920th of 2000 higher than 1,079 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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