<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/NCT04471350</url>
  </required_header>
  <id_info>
    <org_study_id>ETC 2018-004</org_study_id>
    <nct_id>NCT04471350</nct_id>
  </id_info>
  <brief_title>Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery</brief_title>
  <official_title>Post-market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Spine Surgery</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>
      Prospective, multi-center, multi-national post-market study evaluating the performance and&#xD;
      safety HEMOBLAST™ Bellows in spine surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multi-center, multi-national post-market study evaluating the performance and&#xD;
      safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6&#xD;
      sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Indication withdrawn&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Achievement of Hemostasis</measure>
    <time_frame>Intraoperatively, expected within 3-10 minutes of application</time_frame>
    <description>The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Adverse Device Effects (SADEs)</measure>
    <time_frame>4 weeks +/- 2 weeks</time_frame>
    <description>The rate of occurrence of serious adverse events deemed by the Investigator to be possibly, probably, or definitely related to HEMOBLAST™ Bellows</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-bleeding at Target Bleeding Site</measure>
    <time_frame>Intraoperative, prior to surgical closure of the subject</time_frame>
    <description>The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operation due to bleeding</measure>
    <time_frame>Post-operatively, expected within 1-28 days of the surgical procedure</time_frame>
    <description>The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Hemostasis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HEMOBLAST™ Bellows</intervention_name>
    <description>Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in spine surgery.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects undergoing spine surgery that meet all of the inclusion criteria and none of the&#xD;
        exclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Pre-operative Inclusion Criteria:&#xD;
&#xD;
          -  Patient is undergoing a non-emergent spine surgery&#xD;
&#xD;
          -  Patient is willing and able to give prior written informed consent for investigation&#xD;
             participation;&#xD;
&#xD;
          -  Patient is 18 years of age or older.&#xD;
&#xD;
        Intra-operative Inclusion Criteria&#xD;
&#xD;
          -  Patient has one or more target bleeding sites (TBS) for which control of bleeding by&#xD;
             conventional procedures is ineffective or impractical.&#xD;
&#xD;
          -  The TBS(s) has been treated with HEMOBLAST™ Bellows per instructions for use.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is pregnant, planning on becoming pregnant during the follow-up period, or&#xD;
             actively breast-feeding;&#xD;
&#xD;
          -  Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or&#xD;
             any other component(s) of the hemostatic agent;&#xD;
&#xD;
          -  Patient has religious or other objections to porcine, bovine, or human components;&#xD;
&#xD;
          -  Patient has any other contraindications, warnings, precautions of the Approved&#xD;
             Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion&#xD;
&#xD;
          -  Patient is not appropriate for inclusion in the clinical trial, per the medical&#xD;
             opinion of the Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre-Marie Longis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>L'Hôpital privé du Confluent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>L'Hôpital privé du Confluent</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04471350
org study id: ETC 2018-004
nct id: NCT04471350
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Prospective, multi-center, multi-national post-market study evaluating the performance and
      safety HEMOBLAST™ Bellows in spine surgery
Prospective, multi-center, multi-national post-market study evaluating the performance and
      safety HEMOBLAST™ Bellows in spine surgery. Up to 80 subjects will be enrolled at up to 6
      sites.
observational model: Cohort
time perspective: Prospective
measure: Achievement of Hemostasis
time frame: Intraoperatively, expected within 3-10 minutes of application
description: The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.
measure: Incidence of Serious Adverse Device Effects (SADEs)
time frame: 4 weeks +/- 2 weeks
description: The rate of occurrence of serious adverse events deemed by the Investigator to be possibly, probably, or definitely related to HEMOBLAST™ Bellows
measure: Re-bleeding at Target Bleeding Site
time frame: Intraoperative, prior to surgical closure of the subject
description: The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows
measure: Re-operation due to bleeding
time frame: Post-operatively, expected within 1-28 days of the surgical procedure
description: The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows
intervention type: Device
intervention name: HEMOBLAST™ Bellows
description: Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in spine surgery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre-Marie Longis, MD
role: Principal Investigator
affiliation: L'Hôpital privé du Confluent
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No