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NCT01300559 · ClinicalTrials.gov registry record · Phase 4
TissueLink Study During Multi-Level Spine Surgery
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01300559 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 60 participants.
The verdict
NCT01300559, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The overall objective of the investigators research is to test the clinical efficacy of the TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin loss intraoperatively. This is a prospective, randomized investigation that will be performed at Duke University Medical Center (DUMC). The overall goal of this study is to evaluate the efficacy of Tissue Link HemoSealing system in minimizing hemoglobin loss preoperatively, intraoperatively and postoperatively for patients undergoing multilevel elective spinal surgery. Not greater than eighty patients scheduled for elective, multi-level decompression and fusion spinal surgery with Dr. William Richardson will be randomized into two groups. Unipolar electrocautery will be used for intraoperative coagulation in one group and the Tissuelink device plus Unipolar electrocautery in the other. These are frequently performed cases with significant blood loss but otherwise low morbidity/mortality that would benefit from more effective intraoperative coagulation.
Interventions
- DEVICE Tissuelink device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-04 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01300559
The ClinicalTrials.gov registry entry for NCT01300559 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 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 1 intervention - of which Tissuelink device is the first listed.
NCT01300559 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01300559 about?
NCT01300559 is a clinical study titled "TissueLink Study During Multi-Level Spine Surgery". The overall objective of the investigators research is to test the clinical efficacy of the TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin loss intraoperatively. This is a prospective, randomized investigation that will be performed at Duke University M...
What is the current status of trial NCT01300559?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2006-04. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01300559?
The interventions under investigation include: Tissuelink device (DEVICE).
Who is sponsoring clinical trial NCT01300559?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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