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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 51 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00638014
The ClinicalTrials.gov registry entry for NCT00638014 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rapid Sternal Closure System is the first listed.
NCT00638014 reports 0 study locations.
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.
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