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Salient Aquamantys Spine Trial

This study has been terminated.
(Study terminated due to Medtronic acquisition)
Sponsor:
Information provided by (Responsible Party):
Salient Surgical Technologies
ClinicalTrials.gov Identifier:
NCT01331499
First received: April 6, 2011
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss.


Condition Intervention Phase
Blood Loss
Device: Bipolar Sealer (Aquamantys)
Procedure: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Post-Market, Prospective, Multicenter, Randomized Trial Comparing the Use of Standard of Care Blood Sparing Techniques With and Without the Aquamantys System to Facilitate Hemostasis in Subjects Undergoing Multi-level Spinal Fusions

Resource links provided by NLM:


Further study details as provided by Salient Surgical Technologies:

Primary Outcome Measures:
  • Actual Peri-operative Blood Loss [ Time Frame: Up to 72 hours post-operatively ] [ Designated as safety issue: No ]
    Actual blood loss (ABL) will be calculated using a study specified formula using laboratory data from up to 72 hours post-surgery. ABL will be compared between treatment groups


Secondary Outcome Measures:
  • Frequency and volume of transfusions [ Time Frame: Up to 72 hours post-operatively ] [ Designated as safety issue: No ]
    The frequency and volume of transfusions will be measured between treatment groups

  • Reduction in hemoglobin and hematocrit values post-operatively [ Time Frame: Upto 72 hours post-operatively ] [ Designated as safety issue: No ]
    The reduction in hemoglobin and hematocrit values will be evaluated between the two treatment groups

  • Length of stay costs and operativ time [ Time Frame: Up to 21 days post-operatively ] [ Designated as safety issue: No ]
    Total length of staycosts and operative time will be compared between treatment groups.


Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bipolar Sealer
Standard of care blood sparing techniques with bipolar sealer
Device: Bipolar Sealer (Aquamantys)
Standard of care blood sparing techniques along with the use of bipolar sealer
Other Name: Aquamantys
Active Comparator: Control
Standard of care blood sparing techniques without the use of bipolar sealer
Procedure: Standard of Care
Standard of care blood sparing techniques without the useof bipolar sealer

Detailed Description:

The primary objective of the study is to assess the effectiveness of Aquamantys in reducing peri-operative blood loss compared with standard electrocautery

Secondary objectives include :

  • Rate and volume of transfusions
  • Evaluating the reduction in hemoglobin and hematocrit values post- operatively
  • LOS costs, and operative time
  • Gathering operator feedback on qualitative criteria, including ease of use and surgical visualization between the two treatment groups
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be candidate for three level (or greater) fusion surgery from T1 to S1 utilizing a direct posterior approach
  2. Male or female 18 to 70 years of age (inclusive)
  3. Must sign the IRB approved Informed Consent Form

Exclusion Criteria:

  1. Undergoing spinal fusion for < 3 lumbar levels, or using an approach other than direct posterior
  2. Undergoing an interbody fusion
  3. Planned use of hypotensive anaesthesia
  4. Pregnant or lactating
  5. Morbid obesity, defined as Body Mass Index (BMI) greater than 40
  6. Previously diagnosed coagulopathy or bleeding diasthesis
  7. Currently, or within the previous 7 days prior to surgery, taking any medications that would produce bleeding diathesis including, but not limited to NSAIDs, aspirin, clopidogrel (Plavix), ticlopidine, or valproic acid
  8. History of significant cardiac disorders that would necessitate special fluid management protocols
  9. Serious trauma other than that confined to the spine
  10. History of acute myocardial infarction and/or acute angina within the past year prior to enrollment
  11. PT/INR >1.3 in the 14 days prior to surgery
  12. PTT > 40 in the 14 days prior to surgery
  13. Platelet count <100K in the 14 days prior to surgery
  14. Based on clinical history, physical exam and subject presentation, subject has or is suspected to have a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements
  15. Prisoner or transient
  16. Enrolled in another drug or device investigational study (currently or within past 30 days)
  17. Unable or unwilling to sign the Informed Consent Form or comply with protocol specified procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331499

Locations
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Salient Surgical Technologies
Investigators
Principal Investigator: Jeffrey Fischgrund, M.D. William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Salient Surgical Technologies
ClinicalTrials.gov Identifier: NCT01331499     History of Changes
Other Study ID Numbers: SAL-SP-10-001
Study First Received: April 6, 2011
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Salient Surgical Technologies:
Blood loss
transfusions
instrumented spinal fusion

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014