Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

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.

Study Overview

• Status: Withdrawn
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: HEMOBLAST Bellows

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing elective, unilateral total knee arthroplasty procedures that meet all eligibility criteria.

Description

Preoperative 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Total Knee Arthroplasty Patients; 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

Device: HEMOBLAST Bellows; The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Serious Adverse Device Effects (SADEs)	The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified	Through study completion, on average 1-2 days post-surgery
Incidence of Unanticipated Serious Adverse Device Effects (UADEs)	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	Through study completion, on average 1-2 days post-surgery

Collaborators and Investigators

• Sponsor: Biom'Up France SAS

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Hemostatics; Coagulants
• Other Study ID Numbers: ETC 2018-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No