<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/NCT03775980</url>
  </required_header>
  <id_info>
    <org_study_id>CIEMAR</org_study_id>
    <nct_id>NCT03775980</nct_id>
  </id_info>
  <brief_title>CIRSE Emprint Microwave Ablation Registry</brief_title>
  <acronym>CIEMAR</acronym>
  <official_title>CIRSE Emprint Microwave Ablation Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiovascular and Interventional Radiological Society of Europe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiovascular and Interventional Radiological Society of Europe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of&#xD;
      Liver Metastases of Colorectal Adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CIRSE Emprint Microwave Ablation Registry (CIEMAR) aims to collect real-life data on the&#xD;
      microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave&#xD;
      Ablation System.&#xD;
&#xD;
      CIEMAR is a prospective, single-arm, multi-centre observational (non-interventional) study&#xD;
      with the objective to observe the &quot;real-life&quot; use of MWA in Europe. The study will observe&#xD;
      the use of the Emprint Microwave Ablation System and all patients included in CIEMAR will&#xD;
      receive treatment with this device as their standard care for CRLM.&#xD;
&#xD;
      Primary endpoint: local tumour control in liver at 12 months after the microwave ablation&#xD;
      treatment on a per lesion basis&#xD;
&#xD;
      Secondary objectives: Overall survival; Overall disease-free survival; Hepatic disease-free&#xD;
      survival; Time to untreatable progression by thermal ablation; Systemic cancer therapy&#xD;
      vacation; Quality of life; Adverse events and toxicity; Economic aspects&#xD;
&#xD;
      In order to measure changes in the quality of life of enrolled patients at different moments&#xD;
      in time before and after treatment with MWA, CIEMAR will incorporate the EORTC QLQ-C30&#xD;
      questionnaire.&#xD;
&#xD;
      Filling out the quality-of-life questionnaire is entirely voluntary for the patient. The&#xD;
      patient will be offered to fill out the questionnaire in his/her mother tongue.&#xD;
&#xD;
      The registry is currently in design and it is planned to start patient inclusion in January&#xD;
      2020. The target is to enrol 1000 patients and patient enrolment will stop two years after&#xD;
      the enrolment of the first patient. A follow-up period of three years has been defined by the&#xD;
      CIEMAR Steering Committee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 4, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2023</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>3 Years</target_duration>
  <primary_outcome>
    <measure>Local Tumor Control</measure>
    <time_frame>12 months</time_frame>
    <description>Local Tumor Control at 12 months on a per lesion basis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE</measure>
    <time_frame>3 years</time_frame>
    <description>Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>Time from observation until death due to any cause (or censoring)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall disease-free-survival</measure>
    <time_frame>3 years</time_frame>
    <description>Time from observation until disease progression or death assessed by the investigators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic disease-free-survival</measure>
    <time_frame>3 years</time_frame>
    <description>Time from observation until disease progression in the liver or death assessed by the investigators.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to untreatable progression by thermal ablation</measure>
    <time_frame>3 years</time_frame>
    <description>Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic cancer therapy vacation</measure>
    <time_frame>3 years</time_frame>
    <description>Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment specific quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Treatment specific quality of life will be assessed using the EORTC-QLQ-C30 questionnaire which includes 28 questions on a scale of 1 to 4 where 1 indicates lower impact of the disease on the patient's quality of life and 4 represents a high impact. Additionally 2 questions using a scale form 1 to 7 are used to generally assess the patient's quality of life where 1 represents poor quality of life and 7 represents an excellent quality of life.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Colorectal Neoplasms Malignant</condition>
  <condition>Neoplasm Metastasis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Emprint Microwave Ablation System</intervention_name>
    <description>Microwave Ablation of colorectal liver metastases</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Proven colorectal liver metastases&#xD;
&#xD;
          -  Treated with EMPRINT Microwave ablation system.&#xD;
&#xD;
          -  Patient referred to MWA by a multidisciplinary tumour board.&#xD;
&#xD;
          -  Signed Informed consent form&#xD;
&#xD;
          -  Intention to treat all liver lesions with radical ablation&#xD;
&#xD;
          -  Intention to completely treat (ablation, resection, SABR) all visible disease&#xD;
&#xD;
          -  Maximum number of 9 liver lesions.&#xD;
&#xD;
          -  Maximum diameter of the largest liver lesion does not exceed 3 cm.&#xD;
&#xD;
          -  Maximum number of 5 lung nodules eligible to be radically treated.&#xD;
&#xD;
          -  Patients treated with a liver first approach may be included if resection of the&#xD;
             primary tumour is planned if applicable.&#xD;
&#xD;
          -  Complete response of treated rectal tumour proven by imaging if applicable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy less than 6 months (palliative treatment)&#xD;
&#xD;
          -  Extrahepatic metastases&#xD;
&#xD;
          -  Ongoing infection (viral/bacterial)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients with liver metastases that cannot be completely and safely treated&#xD;
&#xD;
          -  Active cancers other than CRC&#xD;
&#xD;
          -  Non-resected primary colon cancer&#xD;
&#xD;
          -  Advanced liver disease or evidence of liver insufficiency&#xD;
&#xD;
          -  Uncorrectable coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phillippe L. Pereira, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thierry de Baère, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Departement of therapeutic radiology, Institut Gustave Roussy, Villejuif, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert Bauer, MA</last_name>
    <phone>+43 1 904 2003 37</phone>
    <email>bauer@cirse.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniela Schweiger, PhD</last_name>
    <phone>+43 1 904 2003 54</phone>
    <email>schweiger@cirse.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CIRSE Cardiovascular and Interventional Radiological Society of Europe</name>
      <address>
        <city>Vienna</city>
        <zip>1010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Bauer, MA</last_name>
      <email>bauer@cirse.org</email>
    </contact>
    <contact_backup>
      <last_name>Daniela Schweiger, PhD</last_name>
      <email>schweiger@cirse.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</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>Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03775980
org study id: CIEMAR
nct id: NCT03775980
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of
      Liver Metastases of Colorectal Adenocarcinoma.
The CIRSE Emprint Microwave Ablation Registry (CIEMAR) aims to collect real-life data on the
      microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave
      Ablation System.

      CIEMAR is a prospective, single-arm, multi-centre observational (non-interventional) study
      with the objective to observe the "real-life" use of MWA in Europe. The study will observe
      the use of the Emprint Microwave Ablation System and all patients included in CIEMAR will
      receive treatment with this device as their standard care for CRLM.

      Primary endpoint: local tumour control in liver at 12 months after the microwave ablation
      treatment on a per lesion basis

      Secondary objectives: Overall survival; Overall disease-free survival; Hepatic disease-free
      survival; Time to untreatable progression by thermal ablation; Systemic cancer therapy
      vacation; Quality of life; Adverse events and toxicity; Economic aspects

      In order to measure changes in the quality of life of enrolled patients at different moments
      in time before and after treatment with MWA, CIEMAR will incorporate the EORTC QLQ-C30
      questionnaire.

      Filling out the quality-of-life questionnaire is entirely voluntary for the patient. The
      patient will be offered to fill out the questionnaire in his/her mother tongue.

      The registry is currently in design and it is planned to start patient inclusion in January
      2020. The target is to enrol 1000 patients and patient enrolment will stop two years after
      the enrolment of the first patient. A follow-up period of three years has been defined by the
      CIEMAR Steering Committee.
observational model: Cohort
time perspective: Prospective
measure: Local Tumor Control
time frame: 12 months
description: Local Tumor Control at 12 months on a per lesion basis
measure: Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE
time frame: 3 years
description: Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.
measure: Overall survival
time frame: 3 years
description: Time from observation until death due to any cause (or censoring)
measure: Overall disease-free-survival
time frame: 3 years
description: Time from observation until disease progression or death assessed by the investigators
measure: Hepatic disease-free-survival
time frame: 3 years
description: Time from observation until disease progression in the liver or death assessed by the investigators.
measure: Time to untreatable progression by thermal ablation
time frame: 3 years
description: Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.
measure: Systemic cancer therapy vacation
time frame: 3 years
description: Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.
measure: Treatment specific quality of life
time frame: 1 year
description: Treatment specific quality of life will be assessed using the EORTC-QLQ-C30 questionnaire which includes 28 questions on a scale of 1 to 4 where 1 indicates lower impact of the disease on the patient's quality of life and 4 represents a high impact. Additionally 2 questions using a scale form 1 to 7 are used to generally assess the patient's quality of life where 1 represents poor quality of life and 7 represents an excellent quality of life.
intervention type: Device
intervention name: Emprint Microwave Ablation System
description: Microwave Ablation of colorectal liver metastases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Phillippe L. Pereira, PhD
role: Study Chair
affiliation: Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany
last name: Thierry de Baère, PhD
role: Study Chair
affiliation: Departement of therapeutic radiology, Institut Gustave Roussy, Villejuif, France
last name: Robert Bauer, MA
phone: +43 1 904 2003 37
email: bauer@cirse.org
last name: Daniela Schweiger, PhD
phone: +43 1 904 2003 54
email: schweiger@cirse.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Colorectal Neoplasms
sharing ipd: No