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NCT00638014 · ClinicalTrials.gov registry record · Phase 4
Rapid Sternal Closure System (TALON)
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT00638014: Completed Phase 4 study, sponsored by Duke University.
NCT00638014 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00638014, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves early postoperative recovery as manifested by decreased pain and improved pulmonary function. Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs (surgical wound complication defined as surgically treated sternal wound infection and sternal instability/non-union) as outlined in the protocol. For a given study endpoint, the null hypothesis will be no difference between the Rapid Sternal Closure System group and the control group. The alternative hypothesis will be a difference between 2 groups. The statistical objective of this study is to reject the null hypothesis in favor of the alternative hypothesis.
Primary Outcome
Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).
Interventions
- DEVICE Rapid Sternal Closure System
- DEVICE Conventional wire closure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
What the finished NCT00638014 record still lists
NCT00638014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Rapid Sternal Closure System is the first listed.
NCT00638014 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00638014 about?
NCT00638014 is a clinical study titled "Rapid Sternal Closure System (TALON)". The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves early postoperative recovery as manifested by decreased pain and improved pulmonary function. Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs (surgical wound complic...
What is the current status of trial NCT00638014?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2008-03. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00638014?
The interventions under investigation include: Rapid Sternal Closure System (DEVICE), Conventional wire closure (DEVICE).
Who is sponsoring clinical trial NCT00638014?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00638014's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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