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TissueLink Study During Multi-Level Spine Surgery

NCT01300559 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-02-07

Study results available
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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.

Conditions

  • Low Back Pain

Interventions

DEVICE

Tissuelink device

Tissuelink device plus Unipolar electrocautery

Sponsors & Collaborators

  • Salient Surgical Technologies

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Steven E Hill, MD · Duke University

  • William J Richardson, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2010-09-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01300559 on ClinicalTrials.gov