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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03772912
Study type Observational [Patient Registry]
Source Biom'Up SA
Contact
Status Withdrawn
Phase
Start date December 2018
Completion date December 2019

See also
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