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NCT00458354 · ClinicalTrials.gov registry record · Phase 3
Use of Spinal Sealant System During Spinal Surgery
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
NCT00458354: Completed Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00458354 is a Phase 3 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458354, a Phase 3 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
Study Summary
1. 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 intraoperatively in patients undergoing spinal surgery. 2. 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 up to 90 days post-procedure.
Interventions
- DEVICE Spinal Sealant
- PROCEDURE Standard Methods of Closing of the Dura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00458354
The ClinicalTrials.gov registry entry for NCT00458354 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Spinal Sealant is the first listed.
NCT00458354 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00458354 about?
NCT00458354 is a clinical study titled "Use of Spinal Sealant System During Spinal Surgery". 1. 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 intraoperatively in patients undergoing spinal surgery. 2. To evaluate the safety and efficacy of the Spinal Sealant ...
What is the current status of trial NCT00458354?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2006-01. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00458354?
The interventions under investigation include: Spinal Sealant (DEVICE), Standard Methods of Closing of the Dura (PROCEDURE).
Who is sponsoring clinical trial NCT00458354?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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