<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/NCT03753789</url>
  </required_header>
  <id_info>
    <org_study_id>NEU_2017_03</org_study_id>
    <nct_id>NCT03753789</nct_id>
  </id_info>
  <brief_title>Ablation Confirmation Study</brief_title>
  <official_title>A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ethicon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ethicon, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE&#xD;
      MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing&#xD;
      ablation of a soft tissue liver lesion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, single-arm, multicenter study that will generate clinical data on 100 adult&#xD;
      patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software&#xD;
      in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed&#xD;
      tomography (CT) image processing software package available as an optional feature for use&#xD;
      with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display&#xD;
      and processing during ablation procedures to assist physicians in identifying ablation&#xD;
      targets, assessing optimal ablation probe placement, and confirming the adequacy of the&#xD;
      ablation margin.&#xD;
&#xD;
      All ablations will be performed percutaneously by an interventional radiologist while the&#xD;
      patient is under general anesthesia or deep conscious sedation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Combined study endpoints with ongoing registry (NOLA/NEU_2017_04)&#xD;
  </why_stopped>
  <start_date type="Actual">November 5, 2019</start_date>
  <completion_date type="Actual">October 12, 2022</completion_date>
  <primary_completion_date type="Actual">October 12, 2022</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>Percentage of patients where probe repositioning is suggested</measure>
    <time_frame>Day of ablation (day 0)</time_frame>
    <description>The percentage of patients for whom probe reposition is suggested by the AC software due to suboptimal initial probe placement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients where re-ablation is suggested</measure>
    <time_frame>Day of ablation (day 0)</time_frame>
    <description>The percentage of patients for whom re-ablation is suggested by the AC software due to insufficient margins.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Adverse Events</measure>
    <time_frame>6 weeks post-ablation</time_frame>
    <description>Patients will be evaluated for device-related or procedure-related AEs and all SAEs from the time of first probe puncture through study completion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success</measure>
    <time_frame>Day of ablation (day 0)</time_frame>
    <description>Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin). Technical Success will be assessed by the performing physician using AC as a tool, immediately following the ablation procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technique Efficacy</measure>
    <time_frame>6 weeks post-ablation</time_frame>
    <description>Technique Efficacy is defined as the complete ablation of the target lesion(s) with an adequate margin. Technique Efficacy will be assessed by the treating physician, at 30 days post-ablation, via imaging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Resource Utilization #1: Time to perform the ablation procedure,</measure>
    <time_frame>Day of ablation (day 0)</time_frame>
    <description>The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable): Time to perform the ablation procedure, specifically, a) the time elapsed between loading CT dataset into AC and completion of ablation with probe removal, b) the time elapsed between loading CT dataset into AC to plan for the target ablation and last use of AC to plan for the final ablation, and c) the time elapsed between ablation first probe puncture and removal of the last probe at the completion of the ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Resource Utilization #2: Length of hospital stay (if applicable)</measure>
    <time_frame>6 weeks post-ablation</time_frame>
    <description>The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable):&#xD;
Length of hospital stay (if applicable)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physician Confidence Questionnaire</measure>
    <time_frame>Day of ablation (day 0)</time_frame>
    <description>A non-validated 5-point scale (0 meaning 'strongly disagree' and 5 meaning 'strongly agree') questionnaire containing 5 questions for the treating physician asking their confidence in completeness of the ablation before using AC compared to after using AC.</description>
  </other_outcome>
  <other_outcome>
    <measure>EORTC QLQ-C30</measure>
    <time_frame>6 weeks post-ablation</time_frame>
    <description>European Organization for Research and Treatment of Cancer quality of life questionnaire containing 30 questions aimed at cancer patients. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').</description>
  </other_outcome>
  <other_outcome>
    <measure>EORTC QLQ-HCC18</measure>
    <time_frame>6 weeks post-ablation</time_frame>
    <description>European Organization for Research and Treatment of Cancer quality of life questionnaire containing 18 questions aimed at patients with primary liver cancer. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').</description>
  </other_outcome>
  <other_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>6 weeks post-ablation</time_frame>
    <description>The Numeric Pain Rating Scale is a questionnaire where the patient reports their pain utilizing a 0-10 scale (where 0 is 'no pain' and 10 is 'maximum pain'). Patients will complete this questionnaire at every study visit.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Cancer of the Liver</condition>
  <condition>Liver Cancer</condition>
  <condition>Neoplasms, Liver</condition>
  <arm_group>
    <arm_group_label>Microwave Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microwave Ablation</intervention_name>
    <description>NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.</description>
    <arm_group_label>Microwave Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A patient with at least one soft-tissue liver lesion less than or equal to 5cm&#xD;
             undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a&#xD;
             patient cannot have more than 3 lesions ablated during the procedure.&#xD;
&#xD;
          2. Intent to use Ablation Confirmation software (any AC software version permitted)&#xD;
             during the ablation procedure.&#xD;
&#xD;
          3. Written Informed Consent to voluntarily participate in the study, follow CT scan&#xD;
             schedule, and authorize the transfer of his/her data to the Sponsor&#xD;
&#xD;
          4. Patients greater than or equal to 22 years of age&#xD;
&#xD;
          5. Performance status 0-2 (Eastern Cooperative Oncology Group [ECOG]) classification&#xD;
&#xD;
          6. Class A or B functional hepatic reserve based on the Child-Pugh score.&#xD;
&#xD;
          7. Lesion must be visualized by non-contrast enhanced CT scan or the patient must&#xD;
             tolerate contrast and meet institutional guidelines for contrast use based on&#xD;
             glomerular filtration rate (GFR).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active bacterial infection or fungal infection on the day of the ablation.&#xD;
&#xD;
          2. Patients with implantable pacemakers or other electronic implants.&#xD;
&#xD;
          3. Platelet count less than 50,000/mm cubed.&#xD;
&#xD;
          4. Patients with uncorrectable coagulopathy at the time of ablation.&#xD;
&#xD;
          5. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per&#xD;
             site's SOC).&#xD;
&#xD;
          6. Physical or psychological condition which would impair study participation.&#xD;
&#xD;
          7. ASA (American Society of Anesthesiologists) score of great or equal to 4.&#xD;
&#xD;
          8. Use of hydrodissection.&#xD;
&#xD;
          9. Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the&#xD;
             study ablation procedure.&#xD;
&#xD;
         10. INR greater than 1.8.&#xD;
&#xD;
         11. Patient has participated in an investigational clinical study within 30 days of the&#xD;
             screening visit for this study.&#xD;
&#xD;
         12. Patient judged unsuitable for study participation by the performing physician for any&#xD;
             other reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Loma Linda University Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olives View - UCLA Medical Center</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 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>Liver 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/NCT03753789
org study id: NEU_2017_03
nct id: NCT03753789
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE
      MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing
      ablation of a soft tissue liver lesion.
Prospective, single-arm, multicenter study that will generate clinical data on 100 adult
      patients using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software
      in patients undergoing ablation of a soft tissue liver lesion. AC software is a computed
      tomography (CT) image processing software package available as an optional feature for use
      with the NEUWAVE Microwave Ablation System. AC imports images from CT scanners for display
      and processing during ablation procedures to assist physicians in identifying ablation
      targets, assessing optimal ablation probe placement, and confirming the adequacy of the
      ablation margin.

      All ablations will be performed percutaneously by an interventional radiologist while the
      patient is under general anesthesia or deep conscious sedation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients where probe repositioning is suggested
time frame: Day of ablation (day 0)
description: The percentage of patients for whom probe reposition is suggested by the AC software due to suboptimal initial probe placement.
measure: Percentage of patients where re-ablation is suggested
time frame: Day of ablation (day 0)
description: The percentage of patients for whom re-ablation is suggested by the AC software due to insufficient margins.
measure: Rate of Adverse Events
time frame: 6 weeks post-ablation
description: Patients will be evaluated for device-related or procedure-related AEs and all SAEs from the time of first probe puncture through study completion.
measure: Technical Success
time frame: Day of ablation (day 0)
description: Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin). Technical Success will be assessed by the performing physician using AC as a tool, immediately following the ablation procedure.
measure: Technique Efficacy
time frame: 6 weeks post-ablation
description: Technique Efficacy is defined as the complete ablation of the target lesion(s) with an adequate margin. Technique Efficacy will be assessed by the treating physician, at 30 days post-ablation, via imaging.
measure: Hospital Resource Utilization #1: Time to perform the ablation procedure,
time frame: Day of ablation (day 0)
description: The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable): Time to perform the ablation procedure, specifically, a) the time elapsed between loading CT dataset into AC and completion of ablation with probe removal, b) the time elapsed between loading CT dataset into AC to plan for the target ablation and last use of AC to plan for the final ablation, and c) the time elapsed between ablation first probe puncture and removal of the last probe at the completion of the ablation
measure: Hospital Resource Utilization #2: Length of hospital stay (if applicable)
time frame: 6 weeks post-ablation
description: The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable):
Length of hospital stay (if applicable)
measure: Physician Confidence Questionnaire
time frame: Day of ablation (day 0)
description: A non-validated 5-point scale (0 meaning 'strongly disagree' and 5 meaning 'strongly agree') questionnaire containing 5 questions for the treating physician asking their confidence in completeness of the ablation before using AC compared to after using AC.
measure: EORTC QLQ-C30
time frame: 6 weeks post-ablation
description: European Organization for Research and Treatment of Cancer quality of life questionnaire containing 30 questions aimed at cancer patients. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').
measure: EORTC QLQ-HCC18
time frame: 6 weeks post-ablation
description: European Organization for Research and Treatment of Cancer quality of life questionnaire containing 18 questions aimed at patients with primary liver cancer. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').
measure: Numeric Pain Rating Scale
time frame: 6 weeks post-ablation
description: The Numeric Pain Rating Scale is a questionnaire where the patient reports their pain utilizing a 0-10 scale (where 0 is 'no pain' and 10 is 'maximum pain'). Patients will complete this questionnaire at every study visit.
arm group label: Microwave Ablation
arm group type: Experimental
description: NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.
intervention type: Device
intervention name: Microwave Ablation
description: NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.
arm group label: Microwave Ablation
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: Germany
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Liver Neoplasms