Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6 sites.
Study Type
OBSERVATIONAL
Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in spine surgery.
L'Hôpital privé du Confluent
Nantes, France
Achievement of Hemostasis
The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.
Time frame: Intraoperatively, expected within 3-10 minutes of application
Incidence of Serious Adverse Device Effects (SADEs)
The rate of occurrence of serious adverse events deemed by the Investigator to be possibly, probably, or definitely related to HEMOBLAST™ Bellows
Time frame: 4 weeks +/- 2 weeks
Re-bleeding at Target Bleeding Site
The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows
Time frame: Intraoperative, prior to surgical closure of the subject
Re-operation due to bleeding
The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows
Time frame: Post-operatively, expected within 1-28 days of the surgical procedure
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