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

Not Applicable

Completed

• Conditions: Cardiothoracic Surgery
• Interventions: Device: HEMOBLAST Bellows; Device: FLOSEAL

• Registration Number: NCT03725098
• Lead Sponsor: Biom'Up France SAS

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Study Start: 2019-03-01
• Primary Completion: 2019-06-28
• Study Completion: 2019-06-28
• Results First Submitted: 2019-12-19
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-07
• Last Update Submitted: 2020-01-07
• Results First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEMOBLAST Bellows (Hemostatic Device)	HEMOBLAST Bellows	Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use
FLOSEAL (Hemostatic Device)	FLOSEAL	Bleeding sites will be treated with FLOSEAL per its approved Indications for Use

Primary Outcome Measures

Name	Time	Method
3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes	Intraoperative	The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.

Secondary Outcome Measures

Name	Time	Method
5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes	Intraoperative	The secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes.

Trial Locations

Locations (4)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States

Kaiser Permanente Moanalua Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States