Status:
WITHDRAWN
Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Lead Sponsor:
Biom'Up France SAS
Conditions:
Abdominoplasty
Eligibility:
All Genders
Brief 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.
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 primary full abdominoplasty procedure without concomitant liposuction; 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 Indications for Use
Key Trial Info
Start Date :
November 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03770195
Start Date
November 13 2018
End Date
December 12 2018
Last Update
December 14 2018
Active Locations (1)
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1
Hunstad Kortesis Bharti Cosmetic Surgery
Huntsville, North Carolina, United States, 28078