<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/NCT02969096</url>
  </required_header>
  <id_info>
    <org_study_id>AAAA</org_study_id>
    <nct_id>NCT02969096</nct_id>
  </id_info>
  <brief_title>Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma</brief_title>
  <official_title>Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation&#xD;
      therapy for hepatic carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients&#xD;
      undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</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>Rate of complete tumor ablation</measure>
    <time_frame>Up to 4 weeks post surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to 4 weeks post surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Liver Neoplasms</condition>
  <arm_group>
    <arm_group_label>Targeted Cryoablation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>liver cancer patients received targeted cryoablation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Targeted Cryoablation Therapy</intervention_name>
    <description>A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.</description>
    <arm_group_label>Targeted Cryoablation Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of liver cancer based on histology or the current accepted radiological&#xD;
             measures.&#xD;
&#xD;
          -  Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each&#xD;
             tumor size≤ 3cm.&#xD;
&#xD;
          -  Life expectancy: Greater than 3 months.&#xD;
&#xD;
          -  Patients' liver function is Child-pugh A or B.&#xD;
&#xD;
          -  Ability to understand the study protocol and a willingness to sign a written informed&#xD;
             consent document.&#xD;
&#xD;
          -  Unable to receive operative surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other primary tumor except liver cancer.&#xD;
&#xD;
          -  History of coagulation disorders or anemia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>qing wu, Bachelor</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Longhua Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Longhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</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>Liver Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02969096
org study id: AAAA
nct id: NCT02969096
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation
      therapy for hepatic carcinoma.
A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients
      undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of complete tumor ablation
time frame: Up to 4 weeks post surgery
measure: Adverse Events
time frame: Up to 4 weeks post surgery
arm group label: Targeted Cryoablation Therapy
arm group type: Experimental
description: liver cancer patients received targeted cryoablation therapy.
intervention type: Procedure
intervention name: Targeted Cryoablation Therapy
description: A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.
arm group label: Targeted Cryoablation Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: qing wu, Bachelor
role: Study Director
affiliation: Shanghai Longhua Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Liver Neoplasms
mesh term: Carcinoma, Hepatocellular
sharing ipd: Undecided