Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

Biom'Up

Status: Withdrawn

Conditions: Abdominoplasty

Treatments: Device: HEMOBLAST Bellows

Study type: Observational

Funder types: Industry

Identifiers

NCT03770195

ETC 2018-003

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

0 participants in 1 patient group

Abdominoplasty Patients

Description:

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

Treatment:

Device: HEMOBLAST Bellows