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NCT00581399 · ClinicalTrials.gov registry record · Phase 2
A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery
A Phase 2 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT00581399: Completed Phase 2 study, sponsored by University of California, Irvine.
NCT00581399 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581399, a Phase 2 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
The purpose of this study is to compare a new high vacuum pressure chest drainage system (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac surgeries. The new system uses smaller diameter drainage tubing to remove blood from the chest after open heart surgery. This is less painful to the patient and should help the patient to breathe better after operation. Preliminary data suggests that the high vacuum suction is effective and practical, and could actually reduce the amount of chest tube bleeding after surgery without compromising heart function. This new high vacuum drainage system was approved by the FDA in 2002. Subsequent testing at University of California, Irvine indicated that this unique system may allow the surgeon to predict excessive postoperative bleeding before the patient is transferred out of the operating room, thus adding safety, convenience, and cost effectiveness to their use.
Primary Outcome
The outcome is to measure the amount of postoperative bleeding in cardiac surgery patients from the time the chest is completely closed until the chest tube is pulled out.
Interventions
- DEVICE NO-NUMO™ High Vacuum Body Cavity Drainage System
- DEVICE PVC Chest Tube
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
What the finished NCT00581399 record still lists
NCT00581399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which NO-NUMO™ High Vacuum Body Cavity Drainage System is the first listed.
NCT00581399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581399 about?
NCT00581399 is a clinical study titled "A Randomized Multicenter Clinical Study On the High Vacuum Body Cavity Drainage System Following Open Heart Surgery". The purpose of this study is to compare a new high vacuum pressure chest drainage system (NO-NUMO™) with the standard low vacuum pressure drainage system already in use in cardiac surgeries. The new system uses smaller diameter drainage tubing to remove blood from the chest after open heart surgery....
What is the current status of trial NCT00581399?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2006-09. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00581399?
The interventions under investigation include: NO-NUMO™ High Vacuum Body Cavity Drainage System (DEVICE), PVC Chest Tube (DEVICE).
Who is sponsoring clinical trial NCT00581399?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00581399's enrollment target sits among peer trials
94 764th of 2000 higher than 1,235 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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