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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). 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.
Primary Outcome
Percentage (%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or control) defined as either Success (A watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds); or Failure (A non-watertight closure of the dural repair intra-operatively after assigned treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 10-15 seconds). This will be determined intraoperativel
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 |
What the finished NCT00458354 record still lists
NCT00458354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Spinal Sealant is the first listed.
NCT00458354 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458354's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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