The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.
HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical. This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites. The subjects will be followed at hospital charge and 6 weeks postoperatively. The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators. Secondary endpoints of this clinical investigation consist of: * Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application; * Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application; * Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and * Incidence of adverse events through final follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
University of Southern California
Los Angeles, California, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Danville Orthopedic Clinic
Danville, Virginia, United States
Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators
The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.
Time frame: Intraoperative
Hemostatic Within 6 Minutes
Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application
Time frame: Intraoperative
Hemostasis Within 10 Minutes
Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application
Time frame: Intraoperative
Hemostasis Within 3 Minutes
Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application
Time frame: Intraoperative
Adverse Events
Incidence of adverse events through final follow-up
Time frame: 6 +/- 2 weeks after implant
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