Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

NCT03770195 | Withdrawn FDA Device

• 1 other identifier: ETC 2018-003
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominoplasty

Keywords

Hemostatics; Coagulants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Serious Adverse Device Effects (SADEs)

  Through study completion, on average 14 days post-surgery

• Incidence of Unanticipated Serious Adverse Device Effects (UADEs)

  Through study completion, on average 14 days post-surgery

Study Arms (1)

Abdominoplasty Patients

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

Interventions

HEMOBLAST Bellows DEVICE

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.

Abdominoplasty Patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing elective full abdominoplasty procedures without concomitant liposuction that meet all eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Biom'Up France SAS: lead

Study Sites (1)

Hunstad Kortesis Bharti Cosmetic Surgery

Huntsville, North Carolina, 28078, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: November 13, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)