Cardiothoracic Surgery Clinical Trial
Official title:
Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
The purpose of this study is to evaluate the performance of HEMOBLASTâ„¢ compared to FLOSEAL in cardiothoracic operations.
A maximum of 104 subjects will be enrolled across a maximum of 5 study sites in the United
States.
The estimated duration of the study is approximately 8 months from the time of first subject
enrollment to the last subject enrollment. Enrollment occurs intraoperatively after
confirmation of the intraoperative eligibility criteria. Subjects will undergo intraoperative
performance assessments and then will be discontinued from the study after completion of the
intraoperative visit.
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