A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.
Study Type
OBSERVATIONAL
Enrollment
64
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 gynecological, urological, vascular, ENT and head and neck surgeries.
Uniklinikum
Salzburg, Austria
Centre Hospitalier Universitaire d'Angers
Angers, France
CHU Grenoble
Grenoble, France
Hopital Saint-Joseph
Paris, 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
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 1-30 days of the surgical procedure
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Clinique Rive Gauche
Toulouse, France
Universitatsklinikum Bonn
Bonn, Germany
Kliniken der Stadt Koln, Krankenhaus Merheim
Cologne, Germany
Agaplesion Markus krankenhaus
Frankfurt, Germany
St Franzikus-Hospital
Münster, Germany