Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

Biom'Up

Status

Completed

Conditions

Cardiothoracic Surgery

Treatments

Device: FLOSEAL

Device: HEMOBLAST Bellows

Study type

Interventional

Funder types

Industry

Identifiers

NCT03725098

ETC 2018-005

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

Full description

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.

Enrollment

105 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Preoperative Inclusion Criteria

Subject is undergoing a non-emergent cardiothoracic surgery; and
Subject or an authorized legal representative is willing and able to give prior written informed consent for study participation.

Preoperative Exclusion Criteria

Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
Subject has religious or other objections to porcine or bovine components; and
Subject is not appropriate for inclusion in the clinical study, per the medical opinion of the Investigator.

Intraoperative Inclusion Criteria

Subject does not have an active or suspected infection at the surgical site;
Subject in whom the Investigator is able to identify a Target Bleeding Site (TBS) for which any applicable conventional means for hemostasis are ineffective or impractical; and
Subject has a TBS with minimal, mild, or moderate bleeding