Status:
WITHDRAWN
Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
Lead Sponsor:
Biom'Up France SAS
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
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 th...
Eligibility Criteria
Inclusion
- Preoperative
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03772912
Start Date
December 1 2018
End Date
December 1 2019
Last Update
December 14 2018
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