xml: <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/NCT06033170</url>
    </required_header>
    <id_info>
      <org_study_id>PMCF_PPH 01</org_study_id>
      <nct_id>NCT06033170</nct_id>
    </id_info>
    <brief_title>Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage</brief_title>
    <official_title>Prospective, Single-Arm Confirmatory Clinical Investigation to Demonstrate the Effectiveness, Performance, and Safety of the Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medtrade</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Charite University, Berlin, Germany</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Medtrade</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a post market prospective, single arm clinical investigation to continuously assess&#xD;
        the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade&#xD;
        treatment for uterine postpartum hemorrhage (PPH).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).</measure>
      <time_frame>Successful haemostasis is defined as absence of additional surgical or non-surgical interventions after application of Celox PPH. It is expected that within 2-5 minutes of application, the bleeding will be controlled.</time_frame>
      <description>The rate of patients in whom bleeding is controlled successfully.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Postpartum Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Insertion of CELOX™ PPH trans-vaginally for bleeding control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>There is only one group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CELOX™ PPH</intervention_name>
      <description>Celox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted.</description>
      <arm_group_label>Insertion of CELOX™ PPH trans-vaginally for bleeding control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject or her legally authorized representative is able to understand and provide&#xD;
               consent to participate in the clinical investigation&#xD;
  &#xD;
            -  Female Adult subjects (&gt;18 years of age).&#xD;
  &#xD;
            -  Diagnosis of PPH with suspected uterine atony placental bed bleeding, placenta accreta&#xD;
               or previa within 24 hours after vaginal delivery.&#xD;
  &#xD;
            -  Subjects with coagulation disorders can be included&#xD;
  &#xD;
            -  Minimal Estimated Blood Loss (EBL), to be determined when investigator is ready to&#xD;
               have the Celox™ PPH package opened. 500 ml of EBL for vaginal delivery or 1000 ml for&#xD;
               caesarean section.&#xD;
  &#xD;
            -  Failed first-line intervention of uterotonics and uterine massage/bimanual compression&#xD;
               to stop bleeding. Note: Uterotonic administration may continue concomitant with and&#xD;
               post the Celox™ PPH use.&#xD;
  &#xD;
            -  Subjects with PPH of cervical or vaginal origin.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Subjects who present with, uterine rupture or for any other conditions outside of atonic&#xD;
          post-partum haemorrhage needing other interventional methods or surgery including uterine&#xD;
          artery embolization (UAE).&#xD;
  &#xD;
            -  Pregnancy or incomplete multiple pregnancy&#xD;
  &#xD;
            -  Unresolved uterine inversion.&#xD;
  &#xD;
            -  Current cervical cancer.&#xD;
  &#xD;
            -  Current purulent infection of the vagina, cervix, uterus.&#xD;
  &#xD;
            -  Planned c-section with closed cervix.&#xD;
  &#xD;
            -  Patients requiring trans-abdominal insertion of Celox™ PPH.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anna Maria Dückelmann, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Charite University, Berlin, Germany</affiliation>
    </overall_official>
    <overall_official>
      <last_name>NIK Abdullah, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Raja Perempuan Zainab II - Malaysia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>June Gladman</last_name>
      <phone>+44 (0)1270 500 019</phone>
      <email>June.Gladman@medtrade.co.uk</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postpartum Hemorrhage</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033170
  org study id: PMCF_PPH 01
  nct id: NCT06033170
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a post market prospective, single arm clinical investigation to continuously assess
        the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade
        treatment for uterine postpartum hemorrhage (PPH).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).
  time frame: Successful haemostasis is defined as absence of additional surgical or non-surgical interventions after application of Celox PPH. It is expected that within 2-5 minutes of application, the bleeding will be controlled.
  description: The rate of patients in whom bleeding is controlled successfully.
  arm group label: Insertion of CELOX™ PPH trans-vaginally for bleeding control
  arm group type: Experimental
  description: There is only one group.
  intervention type: Device
  intervention name: CELOX™ PPH
  description: Celox™ PPH is intended to be a physical haemostatic treatment for control and treatment of uterine postpartum hemorrhage (PPH) when conservative management is warranted.
  arm group label: Insertion of CELOX™ PPH trans-vaginally for bleeding control
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anna Maria Dückelmann, MD
  role: Principal Investigator
  affiliation: Charite University, Berlin, Germany
  last name: NIK Abdullah, MD
  role: Principal Investigator
  affiliation: Hospital Raja Perempuan Zainab II - Malaysia
  last name: June Gladman
  phone: +44 (0)1270 500 019
  email: June.Gladman@medtrade.co.uk
  responsible party type: Sponsor
  mesh term: Postpartum Hemorrhage
  mesh term: Hemorrhage
  sharing ipd: No