Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

Withdrawn

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Device: HEMOBLAST Bellows

• Registration Number: NCT03772912
• Lead Sponsor: Biom'Up France SAS

Brief Summary

The purpose of this post-market observational registry is to collect additional data on the safety and effectiveness of the HEMOBLAST™ Bellows device in total knee arthroplasty procedures.

Detailed Description

A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.

Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 10 months from the time of first subject enrollment to completion of the last subject follow up.

Study Timeline

• Status Verified: 2018-12
• Study Start: 2018-12
• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-14
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient is undergoing a unilateral total knee arthroplasty procedure; and
• Patient is willing and able to give written informed consent for registry participation.

Preoperative

Exclusion Criteria

• Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and
• Patient has religious or other objections to porcine, bovine, or human components.

Intraoperative Inclusion Criteria

• Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and
• The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indication for Use.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Knee Arthroplasty Patients	HEMOBLAST Bellows	Patients undergoing primary or revision total knee arthroplasty procedures in which the surgeon elects to use HEMOBLAST Bellows to control minimal, mild, or moderate bleeding for which conventional means of hemostasis are ineffective or impractical

Primary Outcome Measures

Name	Time	Method
Achievement of Hemostasis at the Target Bleeding Site	Intraoperatively, expected within 3-10 minutes of application	The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed

Secondary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Device Effects (SADEs)	Through study completion, on average 1-2 days post-surgery	The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified
Incidence of Unanticipated Serious Adverse Device Effects (UADEs)	Through study completion, on average 1-2 days post-surgery	The incidence of Serious Adverse Events that are both unanticipated and deemed by the investigator to be possibly, probably, or definitely related to the device