Abdominoplasty Clinical Trial
Official title:
Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Verified date | December 2018 |
Source | Biom'Up SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 12, 2018 |
Est. primary completion date | December 12, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility |
Preoperative Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hunstad Kortesis Bharti Cosmetic Surgery | Huntsville | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Biom'Up SA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of Serious Adverse Device Effects (SADEs) | The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified | Through study completion, on average 14 days post-surgery | |
Secondary | Incidence of Unanticipated Serious Adverse Device Effects (UADEs) | The incidence of Serious Adverse Events that are both unanticipated and deemed by the investigator to be possibly, probably, or definitely related to the device | Through study completion, on average 14 days post-surgery |
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