The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows
Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin
University of Southern California
Los Angeles, California, United States
Indiana Spine Group
Carmel, Indiana, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Incidence of Unanticipated Adverse Device Effect (UADE)
incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC).
Time frame: 3 months follow-up
Adverse events (AE)
the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T.
Time frame: 3 months follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Spectrum Medical Inc
Danville, Virginia, United States