NCT01331499

Salient Aquamantys Spine Trial

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Salient Surgical Technologies · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Blood Loss

Interventions

Type	Name	Description
DEVICE	Bipolar Sealer (Aquamantys)	Standard of care blood sparing techniques along with the use of bipolar sealer
PROCEDURE	Standard of Care	Standard of care blood sparing techniques without the useof bipolar sealer

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-12-01
• Completion: 2013-04-01
• First posted: 2011-04-08
• Last updated: 2012-06-07

Locations

3 sites across 1 country: United States