Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

NCT03772912 | Withdrawn FDA Device

• 1 other identifier: ETC 2018-006
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty, Replacement, Knee

Keywords

Hemostatics; Coagulants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Serious Adverse Device Effects (SADEs)

  Through study completion, on average 1-2 days post-surgery

• Incidence of Unanticipated Serious Adverse Device Effects (UADEs)

  Through study completion, on average 1-2 days post-surgery

Study Arms (1)

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

Interventions

HEMOBLAST Bellows DEVICE

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.

Total Knee Arthroplasty Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biom'Up France SAS: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 12, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share