Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
- Conditions
- Abdominoplasty
- Interventions
- Device: HEMOBLAST Bellows
- Registration Number
- NCT03770195
- Lead Sponsor
- Biom'Up France SAS
- 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 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Abdominoplasty Patients HEMOBLAST Bellows Patients undergoing full abdominoplasty procedures in which the surgeon elects to use HEMOBLAST Bellows to control minimal, mild, or moderate bleeding for which conventional means of hemostasis are ineffective or impractical
- Primary Outcome Measures
Name Time Method Achievement of Hemostasis at the Target Bleeding Site Intraoperatively, expected within 3-10 minutes of application The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed.
- Secondary Outcome Measures
Name Time Method Incidence of Serious Adverse Device Effects (SADEs) Through study completion, on average 14 days post-surgery The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified
Incidence of Unanticipated Serious Adverse Device Effects (UADEs) Through study completion, on average 14 days post-surgery 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
Trial Locations
- Locations (1)
Hunstad Kortesis Bharti Cosmetic Surgery
🇺🇸Huntsville, North Carolina, United States