Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

Abdominoplasty Clinical Trial

Official title:

Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03770195
• Other study ID #: ETC 2018-003
• Status: Withdrawn
• Start date: November 13, 2018
• Est. completion date: December 12, 2018

Study information

• Verified date: December 2018
• Source: Biom'Up SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• 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

Related Conditions & MeSH terms

• Abdominoplasty

Intervention

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.

Locations

Country	Name	City	State
United States	Hunstad Kortesis Bharti Cosmetic Surgery	Huntsville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Biom'Up SA

Country where clinical trial is conducted

United States, 

Outcome

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