An observational study in Abdominoplasty, sponsored by Biom'Up France SAS. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-12-14.
Sponsored by Biom'Up France SAS · Observational
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.
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.
Biom'Up France SAS is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects undergoing elective full abdominoplasty procedures without concomitant liposuction that meet all eligibility criteria.
Preoperative Inclusion Criteria:
Preoperative Exclusion Criteria:
Intraoperative Inclusion Criteria
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
Device: HEMOBLAST Bellows
The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
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.
Time frame: Intraoperatively, expected within 3-10 minutes of application
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
Time frame: Through study completion, on average 14 days post-surgery
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
Time frame: Through study completion, on average 14 days post-surgery
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Biom'Up France SAS