MedTrace Logo

Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

NCT02164201 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2015-07-29

No results posted yet for this study

Summary

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.

Conditions

  • Cardiovascular Procedures
  • Thoracic Aortic Aneurysm
  • Aortic Valve Replacement
  • Type A Aortic Dissection

Sponsors & Collaborators

  • CryoLife Europa

    lead INDUSTRY

Principal Investigators

  • Bernhard Voss, PD Dr Med · Deutsches Herzzentrum Muenchen

  • Ottavio Alfieri, Professor · San Raffale Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Germany
  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02164201 on ClinicalTrials.gov