<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/NCT02255890</url>
  </required_header>
  <id_info>
    <org_study_id>Registry IRE Nanoknife®</org_study_id>
    <nct_id>NCT02255890</nct_id>
  </id_info>
  <brief_title>Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device</brief_title>
  <official_title>Registry of Irreversible Electroporation for the Ablation of Prostate Cancer With Use of Nanoknife Device; A Multi-Center, International Registry to Evaluate the Treatment of Prostate Cancer in Terms of Recurrence, Functional Outcomes and Safety.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Research Office of the Endourological Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Research Office of the Endourological Society</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as&#xD;
      well as the change in functional outcomes (e.g. incontinence or erectile function) from&#xD;
      baseline. Secondary objectives are to establish which indications lead to treatment with IRE&#xD;
      Nanoknife® setting and safety assessment measured by number of complications and adverse&#xD;
      events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an international prospective observational multi-center study in which data on&#xD;
      consecutive patients for 5 years with prostate cancer who undergo IRE are collected. Data&#xD;
      from each patient will be collected at participating centers over a 5-year period. Patients'&#xD;
      data at baseline visit (pre-IRE), peri-operative data and follow up for 5 years will be&#xD;
      recorded. Follow up data will be collected according to the following schedule:&#xD;
&#xD;
      1 - 2 weeks after surgery&#xD;
&#xD;
        1. st year: every 3 months&#xD;
&#xD;
        2. nd year: every three months&#xD;
&#xD;
        3. rd year: every 6 months&#xD;
&#xD;
        4. th and 5th year: once a year. Data from participating centers will be collected through&#xD;
           electronic Case Report Forms (eCRFs), with use of an online Data Management System&#xD;
           (DMS), which is located and maintained at the CROES Office. The data collection or&#xD;
           patient participation in this study does not interfere with the choice of treatment,&#xD;
           sample collection, procedures and the treatment itself, which should entirely follow&#xD;
           standard hospital practices, including the follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Actual">June 2020</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>5 Years</target_duration>
  <primary_outcome>
    <measure>to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>to establish which indications lead to treatment with IRE Nanoknife® setting</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety assessment measured by number of complications and adverse events</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">361</enrollment>
  <condition>Prostate Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population comprises those patients diagnosed with histologically confirmed&#xD;
        prostate cancer and are scheduled for treatment with IRE Nanoknife®.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is diagnosed with histologically confirmed prostate cancer&#xD;
&#xD;
          -  Is scheduled for IRE Nanoknife®&#xD;
&#xD;
          -  Has signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No specific exclusion criteria are defined.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean de la Rosette</last_name>
    <role>Study Chair</role>
    <affiliation>Clinical Research Office of the Endourological Society</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AMC University Hospital</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://www.croesoffice.org</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2020</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>Prostatic 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/NCT02255890
org study id: Registry IRE Nanoknife®
nct id: NCT02255890
lead sponsor: 
has dmc: No
The aim of this registry is to assess the recurrence of prostate cancer at 1 and 5 years, as
      well as the change in functional outcomes (e.g. incontinence or erectile function) from
      baseline. Secondary objectives are to establish which indications lead to treatment with IRE
      Nanoknife® setting and safety assessment measured by number of complications and adverse
      events.
This is an international prospective observational multi-center study in which data on
      consecutive patients for 5 years with prostate cancer who undergo IRE are collected. Data
      from each patient will be collected at participating centers over a 5-year period. Patients'
      data at baseline visit (pre-IRE), peri-operative data and follow up for 5 years will be
      recorded. Follow up data will be collected according to the following schedule:

      1 - 2 weeks after surgery

        1. st year: every 3 months

        2. nd year: every three months

        3. rd year: every 6 months

        4. th and 5th year: once a year. Data from participating centers will be collected through
           electronic Case Report Forms (eCRFs), with use of an online Data Management System
           (DMS), which is located and maintained at the CROES Office. The data collection or
           patient participation in this study does not interfere with the choice of treatment,
           sample collection, procedures and the treatment itself, which should entirely follow
           standard hospital practices, including the follow up.
observational model: Cohort
time perspective: Prospective
measure: to assess the recurrence of prostate cancer at 1 and 5 years, as well as the change in functional outcomes (e.g. incontinence or erectile function) from baseline
time frame: 10 years
measure: to establish which indications lead to treatment with IRE Nanoknife® setting
time frame: 5 years
measure: safety assessment measured by number of complications and adverse events
time frame: 5 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jean de la Rosette
role: Study Chair
affiliation: Clinical Research Office of the Endourological Society
facility: 
country: Netherlands
url: http://www.croesoffice.org
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Neoplasms