- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770195
Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
Study Overview
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
Contacts and Locations
Study Locations
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North Carolina
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Huntsville, North Carolina, United States, 28078
- Hunstad Kortesis Bharti Cosmetic Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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.
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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
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The ability of HEMOBLAST Bellows to achieve hemostasis (i.e.
cessation of bleeding) at the target bleeding site will be assessed.
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Intraoperatively, expected within 3-10 minutes of application
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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
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The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified
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Through study completion, on average 14 days post-surgery
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Incidence of Unanticipated Serious Adverse Device Effects (UADEs)
Time Frame: Through study completion, on average 14 days post-surgery
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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
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Through study completion, on average 14 days post-surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ETC 2018-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Abdominoplasty
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LUTRONIC CorporationUnknown
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Regen Lab SAUnknown
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Silk Medical Aesthetics, Inc.Completed
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South Valley UniversityUnknown
-
Brugmann University HospitalActive, not recruiting
-
Mansoura UniversityUnknown
-
Loma Linda UniversityWithdrawn
-
Syneron MedicalUnknownAbdominoplastyUnited States
-
Wake Forest University Health SciencesEnrolling by invitationAbdominoplasty | PanniculectomyUnited States
Clinical Trials on HEMOBLAST Bellows
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Biom'Up France SASWithdrawn
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Biom'Up France SASCompletedHemostasisGermany, France, Austria
-
Biom'Up France SASTerminatedHemostasisGermany, France, Austria
-
Biom'Up France SASCompletedCardiothoracic SurgeryUnited States
-
Biom'Up France SASWithdrawnArthroplasty, Replacement, Knee
-
InotremRichmond Pharmacology LimitedCompletedHealthy SubjectsUnited Kingdom
-
Dilon Technologies Inc.Syneos HealthActive, not recruiting
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University Hospital, Gentofte, CopenhagenUnknown