<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/NCT03243734</url>
  </required_header>
  <id_info>
    <org_study_id>017</org_study_id>
    <nct_id>NCT03243734</nct_id>
  </id_info>
  <brief_title>trūFreeze® Palliative Esophageal Cancer</brief_title>
  <official_title>A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients With Persistent Local Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>US Endoscopy Group Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>US Endoscopy Group 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, open label, non-controlled single arm, multi-center study The primary objective&#xD;
      is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of&#xD;
      subjects who have been diagnosed with persistent local esophageal cancer and who are not&#xD;
      surgical candidates or have completed or declined systemic therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of cryotherapy delivered with the trūFreeze® System via noncontact spray ablates the&#xD;
      cancer cells while allowing adjacent normal tissue to regenerate. When the liquid nitrogen is&#xD;
      delivered to the malignant lesion the cancer cells undergo ablation induced by intracellular&#xD;
      water being frozen in place such that ice crystals are formed. These ice crystals aggregate&#xD;
      quickly causing immediate intracellular energy producing organelles to be destroyed leading&#xD;
      to a non-viable cell. Subsequent tumor sloughing and absorption of apoptotic cells occurs&#xD;
      with a subsequent debulking of the tumor mass. Normal tissue will regenerate as&#xD;
      re-epithelialization occurs. The extreme cold of -196 degrees Celsius or a &quot;hard freeze&quot;&#xD;
      leads to more extensive primary cell death over a shorter freeze time as compared to&#xD;
      cryoprobes. A reduction of overall tumor obstruction in the esophageal lumen can reduce&#xD;
      symptoms of dysphagia, delay the time until stent is needed, provide palliative care for&#xD;
      patients for whom additional tri-modal therapies are not an option, and may increase quality&#xD;
      of life in esophageal cancer patients. The studies conducted to date have provided&#xD;
      documentation of the safety and effectiveness of spray cryotherapy (SCT) when used for&#xD;
      malignancies in the esophagus. Measures of dysphagia relief have been described in peer&#xD;
      reviewed literature. This study aims to provide much needed HRQOL information as well as&#xD;
      additional tumor characteristics before and after SCT. A cohort of patients with locally&#xD;
      persistent esophageal cancer will be studied in up to twelve (12) centers in the United&#xD;
      States to provide important HRQOL data and more a comprehensive understanding of clinical&#xD;
      tumor response post SCT. In the proposed study, the trūFreeze® System spray cryotherapy&#xD;
      procedure will be performed during endoscopy. Each SCT procedure will be performed&#xD;
      endoscopically at clinically indicated intervals of 6 weeks +/- 3 weeks. Total procedure&#xD;
      dosimetry will be delivered at the discretion of the Investigator based on tumor location and&#xD;
      patient tolerability. After each procedure at defined intervals, patients will be contacted&#xD;
      and QOL symptom related information will be collected. If at any point an Investigator&#xD;
      determines that a subject is not a candidate for further spray cryotherapy or is unable to&#xD;
      tolerate additional procedures, they will be contacted via telephone to ascertain HRQOL&#xD;
      information. Subject participation will last up to two years or until death&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 6, 2017</start_date>
  <completion_date type="Anticipated">March 6, 2024</completion_date>
  <primary_completion_date type="Actual">July 13, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline EORTC at 14 days post cryotherapy procedure</measure>
    <time_frame>14 days post spray cryotherapy</time_frame>
    <description>Validated Cancer Specific Quality of Life Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline dysphagia scale at 14 days post cryotherapy procedure</measure>
    <time_frame>14 days post spray cryotherapy</time_frame>
    <description>Dysphagia Severity Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)</measure>
    <time_frame>up to 2 years post SCT procedure</time_frame>
    <description>baseline to procedure other than spray cryotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>up to 2 years post SCT procedure</time_frame>
    <description>SCT to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in the amount of residual tumor from baseline to follow-up cryospray delivery session</measure>
    <time_frame>up to 2 years post SCT procedure</time_frame>
    <description>Describe changes in tumor</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">51</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>trūFreeze® System spray cryotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>trūFreeze® System spray cryotherapy as clinically indicated for symptom relief</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>trūFreeze® System spray cryotherapy</intervention_name>
    <description>Subjects where trūFreeze® System spray cryotherapy is performed</description>
    <arm_group_label>trūFreeze® System spray cryotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females of 18 to 89 years of age.&#xD;
&#xD;
          -  Subject is able to read, understand, and sign a written Informed Consent to&#xD;
             participate in the study.&#xD;
&#xD;
          -  Subject has persistent esophageal cancer with local luminal involvement and who is not&#xD;
             a surgical candidate or has completed or declined systemic therapy.&#xD;
&#xD;
          -  Subject is able to tolerate endoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant, nursing, or planning to get pregnant during study duration.&#xD;
&#xD;
          -  Subjects with an esophageal stent in situ at the time of study enrollment&#xD;
&#xD;
          -  Subject, as deemed by treating investigator has contraindication to endoscopy or Spray&#xD;
             Cryotherapy Procedure.&#xD;
&#xD;
          -  Subject has received radiation within the past 6 weeks&#xD;
&#xD;
          -  Subject has received chemotherapy within the past 2 weeks Subject has received&#xD;
             immunotherapy within 30 days&#xD;
&#xD;
          -  Subject has participated in another clinical study for systemic therapy within 6 weeks&#xD;
             of baseline.&#xD;
&#xD;
          -  Subject has had previous Spray Cryotherapy for esophageal cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicholas Shaheen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Treatment Centers of America Western Regional Medical Center</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Comprehensive Cancer Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hotchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore-Long Island Jewish Medical Center</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spray cryotherapy</keyword>
  <keyword>quality of life</keyword>
  <keyword>symptom reduction</keyword>
  <keyword>esophageal malignancies</keyword>
  <keyword>liquid nitrogen</keyword>
  <keyword>ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal 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/NCT03243734
org study id: 017
nct id: NCT03243734
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Prospective, open label, non-controlled single arm, multi-center study The primary objective
      is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of
      subjects who have been diagnosed with persistent local esophageal cancer and who are not
      surgical candidates or have completed or declined systemic therapy.
The use of cryotherapy delivered with the trūFreeze® System via noncontact spray ablates the
      cancer cells while allowing adjacent normal tissue to regenerate. When the liquid nitrogen is
      delivered to the malignant lesion the cancer cells undergo ablation induced by intracellular
      water being frozen in place such that ice crystals are formed. These ice crystals aggregate
      quickly causing immediate intracellular energy producing organelles to be destroyed leading
      to a non-viable cell. Subsequent tumor sloughing and absorption of apoptotic cells occurs
      with a subsequent debulking of the tumor mass. Normal tissue will regenerate as
      re-epithelialization occurs. The extreme cold of -196 degrees Celsius or a "hard freeze"
      leads to more extensive primary cell death over a shorter freeze time as compared to
      cryoprobes. A reduction of overall tumor obstruction in the esophageal lumen can reduce
      symptoms of dysphagia, delay the time until stent is needed, provide palliative care for
      patients for whom additional tri-modal therapies are not an option, and may increase quality
      of life in esophageal cancer patients. The studies conducted to date have provided
      documentation of the safety and effectiveness of spray cryotherapy (SCT) when used for
      malignancies in the esophagus. Measures of dysphagia relief have been described in peer
      reviewed literature. This study aims to provide much needed HRQOL information as well as
      additional tumor characteristics before and after SCT. A cohort of patients with locally
      persistent esophageal cancer will be studied in up to twelve (12) centers in the United
      States to provide important HRQOL data and more a comprehensive understanding of clinical
      tumor response post SCT. In the proposed study, the trūFreeze® System spray cryotherapy
      procedure will be performed during endoscopy. Each SCT procedure will be performed
      endoscopically at clinically indicated intervals of 6 weeks +/- 3 weeks. Total procedure
      dosimetry will be delivered at the discretion of the Investigator based on tumor location and
      patient tolerability. After each procedure at defined intervals, patients will be contacted
      and QOL symptom related information will be collected. If at any point an Investigator
      determines that a subject is not a candidate for further spray cryotherapy or is unable to
      tolerate additional procedures, they will be contacted via telephone to ascertain HRQOL
      information. Subject participation will last up to two years or until death
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline EORTC at 14 days post cryotherapy procedure
time frame: 14 days post spray cryotherapy
description: Validated Cancer Specific Quality of Life Questionnaire
measure: Change from baseline dysphagia scale at 14 days post cryotherapy procedure
time frame: 14 days post spray cryotherapy
description: Dysphagia Severity Scale
measure: Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)
time frame: up to 2 years post SCT procedure
description: baseline to procedure other than spray cryotherapy
measure: Overall Survival
time frame: up to 2 years post SCT procedure
description: SCT to death
measure: Mean change in the amount of residual tumor from baseline to follow-up cryospray delivery session
time frame: up to 2 years post SCT procedure
description: Describe changes in tumor
arm group label: trūFreeze® System spray cryotherapy
arm group type: Experimental
description: trūFreeze® System spray cryotherapy as clinically indicated for symptom relief
intervention type: Device
intervention name: trūFreeze® System spray cryotherapy
description: Subjects where trūFreeze® System spray cryotherapy is performed
arm group label: trūFreeze® System spray cryotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Nicholas Shaheen, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Esophageal Neoplasms
sharing ipd: No