<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770195</url>
  </required_header>
  <id_info>
    <org_study_id>ETC 2018-003</org_study_id>
    <nct_id>NCT03770195</nct_id>
  </id_info>
  <brief_title>Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty</brief_title>
  <official_title>Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biom'Up France SAS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biom'Up France SAS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this post-market observational registry is to collect additional data on the&#xD;
      safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.&#xD;
&#xD;
      Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data&#xD;
      collection will occur during the surgical procedure as well as during patient follow up and&#xD;
      will follow site standard of care. Subjects will be discontinued from the study after&#xD;
      completion of the final follow up visit. The estimated duration of the study is approximately&#xD;
      6 months from the time of first subject enrollment to completion of the last subject follow&#xD;
      up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Actual">December 12, 2018</completion_date>
  <primary_completion_date type="Actual">December 12, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Achievement of Hemostasis at the Target Bleeding Site</measure>
    <time_frame>Intraoperatively, expected within 3-10 minutes of application</time_frame>
    <description>The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Adverse Device Effects (SADEs)</measure>
    <time_frame>Through study completion, on average 14 days post-surgery</time_frame>
    <description>The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Unanticipated Serious Adverse Device Effects (UADEs)</measure>
    <time_frame>Through study completion, on average 14 days post-surgery</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Abdominoplasty</condition>
  <arm_group>
    <arm_group_label>Abdominoplasty Patients</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HEMOBLAST Bellows</intervention_name>
    <description>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.</description>
    <arm_group_label>Abdominoplasty Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects undergoing elective full abdominoplasty procedures without concomitant liposuction&#xD;
        that meet all eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Preoperative Inclusion Criteria:&#xD;
&#xD;
          -  Patient is undergoing a primary full abdominoplasty procedure without concomitant&#xD;
             liposuction; and&#xD;
&#xD;
          -  Patient is willing and able to give written informed consent for registry&#xD;
             participation&#xD;
&#xD;
        Preoperative Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and&#xD;
&#xD;
          -  Patient has religious or other objections to porcine, bovine, or human components&#xD;
&#xD;
        Intraoperative Inclusion Criteria&#xD;
&#xD;
          -  Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate&#xD;
             bleeding for which conventional means for hemostasis are ineffective or impractical;&#xD;
             and&#xD;
&#xD;
          -  The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indications for Use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hunstad Kortesis Bharti Cosmetic Surgery</name>
      <address>
        <city>Huntsville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemostatics</keyword>
  <keyword>Coagulants</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770195
org study id: ETC 2018-003
nct id: NCT03770195
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Achievement of Hemostasis at the Target Bleeding Site
time frame: Intraoperatively, expected within 3-10 minutes of application
description: The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed.
measure: Incidence of Serious Adverse Device Effects (SADEs)
time frame: Through study completion, on average 14 days post-surgery
description: The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified
measure: Incidence of Unanticipated Serious Adverse Device Effects (UADEs)
time frame: Through study completion, on average 14 days post-surgery
description: 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
arm group label: Abdominoplasty Patients
description: 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
intervention type: Device
intervention name: HEMOBLAST Bellows
description: 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.
arm group label: Abdominoplasty Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No