<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/NCT01671943</url>
  </required_header>
  <id_info>
    <org_study_id>ICMBC-01</org_study_id>
    <nct_id>NCT01671943</nct_id>
  </id_info>
  <brief_title>Cryotherapy for Breast Cancer Trial</brief_title>
  <acronym>ICE-BREACCER</acronym>
  <official_title>Evaluation of Safety and Feasibility of ICE-SENSE3TM , a Cryotherapy Device for Office-based Ultrasound- Guided Treatment of Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IceCure Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IceCure Medical Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical feasibility and safety of the&#xD;
      ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>The rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in-situ carcinoma present upon pathological examination of the surgical resection specimen</measure>
    <time_frame>One month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>One month</time_frame>
    <description>To describe the adverse events associated with cryoablation in these patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>One month</time_frame>
    <description>To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Breast carcinoma up to 2.0 cm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ice-Sense3TM</intervention_name>
    <description>Ice-Sense Cryoprobe</description>
    <arm_group_label>Breast carcinoma up to 2.0 cm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy.&#xD;
             Patients with contralateral disease will remain eligible. Note: Results of ER, PR,&#xD;
             HER-2/neu must be obtained on pre-registration needle core biopsy material.&#xD;
&#xD;
          -  Tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, MRI and&#xD;
             mammogram. The largest dimension measured will be used to determine eligibility.&#xD;
&#xD;
          -  Tumor enhancement on MRI&#xD;
&#xD;
          -  Tumor with &lt;25% intraductal components in the aggregate.&#xD;
&#xD;
          -  Non-pregnant and non-lactating patients. Patients of childbearing potential must have&#xD;
             a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be&#xD;
             amenorrheic for &gt; 12 months to be considered not of childbearing potential.&#xD;
&#xD;
          -  Adequate breast size for safe cryoablation. Patients with breasts too small to allow&#xD;
             safe cryoablation are not eligible as the minimal thickness of the breast tissue does&#xD;
             not lend itself to cryoablation. NOTE: The minimal distance of tumor margins from the&#xD;
             breast skin should be analogous to the surgical margins of a lumpectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal&#xD;
             calcifications, or evidence of excessive DCIS.&#xD;
&#xD;
          -  History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy&#xD;
             and/or lumpectomy for diagnosis/treatment of the index breast cancer.&#xD;
&#xD;
          -  Prior or planned neoadjuvant chemotherapy for breast cancer.&#xD;
&#xD;
          -  Patients with thrombocytopenia and or any other coagulation abnormality&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Pavlista, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague Prague, Czech Republic</name>
      <address>
        <city>Prague</city>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>June 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>February 5, 2015</last_update_submitted>
  <last_update_submitted_qc>February 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>small malignant invasive breast tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01671943
org study id: ICMBC-01
nct id: NCT01671943
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the clinical feasibility and safety of the
      ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in-situ carcinoma present upon pathological examination of the surgical resection specimen
time frame: One month
measure: Adverse events
time frame: One month
description: To describe the adverse events associated with cryoablation in these patients.
measure: Pain assessment
time frame: One month
description: To prospectively gather pain assessment data before and after cryoablation and after surgical resection in these patients
arm group label: Breast carcinoma up to 2.0 cm
arm group type: Experimental
intervention type: Device
intervention name: Ice-Sense3TM
description: Ice-Sense Cryoprobe
arm group label: Breast carcinoma up to 2.0 cm
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David Pavlista, MD
role: Principal Investigator
facility: 
country: Czech Republic
responsible party type: Sponsor
mesh term: Breast Neoplasms