Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

December 12, 2018 updated by: Biom'Up France SAS
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Huntsville, North Carolina, United States, 28078
        • Hunstad Kortesis Bharti Cosmetic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of Hemostasis at the Target Bleeding Site
Time Frame: 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.
Intraoperatively, expected within 3-10 minutes of application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Serious Adverse Device Effects (SADEs)
Time Frame: 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
Through study completion, on average 14 days post-surgery
Incidence of Unanticipated Serious Adverse Device Effects (UADEs)
Time Frame: 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
Through study completion, on average 14 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2018

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

December 14, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ETC 2018-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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