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Clinical Trial Summary

The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty 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 6 months from the time of first subject enrollment to completion of the last subject follow up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03770195
Study type Observational [Patient Registry]
Source Biom'Up SA
Contact
Status Withdrawn
Phase
Start date November 13, 2018
Completion date December 12, 2018

See also
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