Salient Aquamantys Spine Trial

Salient Surgical Technologies

Status and phase: Terminated; Phase 4

Conditions: Blood Loss

Treatments: Procedure: Standard of Care; Device: Bipolar Sealer (Aquamantys)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01331499

SAL-SP-10-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Bipolar Sealer

Experimental group

Description:

Standard of care blood sparing techniques with bipolar sealer

Treatment:

Device: Bipolar Sealer (Aquamantys)

Control

Active Comparator group

Description:

Standard of care blood sparing techniques without the use of bipolar sealer

Treatment:

Procedure: Standard of Care