Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
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|ClinicalTrials.gov Identifier: NCT02164201|
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : July 29, 2015
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
The overall objective of this clinical study is to collect clinical data supporting the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery. This study is intended as a post-market surveillance (follow-up) study.
|Condition or disease|
|Cardiovascular Procedures Thoracic Aortic Aneurysm Aortic Valve Replacement Type A Aortic Dissection|
|Study Type :||Observational|
|Actual Enrollment :||75 participants|
|Official Title:||Post Market Surveillance Study Evaluating the Operative Management of Anastomotic Bleeding by Means of an Adjunctive Application of BioFoam Surgical Matrix in Cardiovascular Surgery|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
- Achievement of haemostasis [ Time Frame: 3 minutes after application ]
- Time to haemostasis [ Time Frame: measured through to 10 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164201
|German Heart Center|
|San Raffale Hospital|
|Principal Investigator:||Bernhard Voss, PD Dr Med||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Ottavio Alfieri, Professor||San Raffale Hospital|