Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 94 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00581399
The ClinicalTrials.gov registry entry for NCT00581399 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.