Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subject is undergoing an elective cardiac or cardiovascular procedure;
* Subject is willing and able to give prior written informed consent for investigation participation; and
* Subject is \> 18 years of age.

• Subject that requires the use of an adjunctive surgical hemostatic agent to the repair site to control generalized oozing following standard repair procedures (such as sutures and staples).

Exclusion Criteria

* • Subject with known hypersensitivity to albumin, bovine products, or glutaraldehyde;

* Subject with active infection (either systemic or in the repair region);
* Subject whose pathology or underlying disease state makes them an unacceptable candidate for a clinical investigation in the opinion of the Investigator;
* Subject diagnosed with a coagulation disorder;
* Subject with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism);
* Subject whose life expectancy is less than that required for the prescribed follow-up duration;
* Subject who is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; or
* Subject who is immunocompromised.

• Any major intraoperative bleeding incidences (i.e., American College of Surgeons Advanced Trauma Life Support Class II, III, or IV Hemorrhage).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No