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Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty

NCT ID: NCT03770195

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-13

Study Completion Date

2018-12-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominoplasty

Keywords

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Hemostatics Coagulants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

HEMOBLAST Bellows

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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


* 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

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biom'Up France SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hunstad Kortesis Bharti Cosmetic Surgery

Huntsville, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ETC 2018-003

Identifier Type: -

Identifier Source: org_study_id