<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/NCT02249975</url>
  </required_header>
  <id_info>
    <org_study_id>CP-0004.A</org_study_id>
    <nct_id>NCT02249975</nct_id>
  </id_info>
  <brief_title>Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium</brief_title>
  <official_title>Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pentax Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pentax Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and performance of the C2 Focal&#xD;
      Cryoablation System in patients with BE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the efficacy and performance of the C2 Focal&#xD;
      Cryoablation System in patients with BE. The study will involve up to 50 subjects with each&#xD;
      subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation&#xD;
      System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's&#xD;
      epithelium with a maximal length of 6 cm.&#xD;
&#xD;
      At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted&#xD;
      for analysis according to Histopathology Protocol.&#xD;
&#xD;
      This study is:&#xD;
&#xD;
        -  Prospective&#xD;
&#xD;
        -  Multi-center&#xD;
&#xD;
        -  Non-randomized&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">October 4, 2017</completion_date>
  <primary_completion_date type="Actual">December 29, 2016</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>Presence of residual Barrett's Esophagus</measure>
    <time_frame>12 weeks</time_frame>
    <description>Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>12 weeks</time_frame>
    <description>All adverse events will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Pain</measure>
    <time_frame>post-procedure through 12 week follow-up</time_frame>
    <description>Patient is asked to rate any pain in the treatment area or with swallowing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Performance</measure>
    <time_frame>12 weeks</time_frame>
    <description>All device performance will be reported</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Barrett's Esophagus</condition>
  <arm_group>
    <arm_group_label>C2 CryoBalloon Focal Ablation System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cryoballoon ablation will be performed on patients with Barrett's Esophagus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>C2 CryoBalloon Focal Ablation System</intervention_name>
    <description>The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken.&#xD;
Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.&#xD;
Evaluations include, but are not limited to the following:&#xD;
Device malfunctions&#xD;
Adverse events&#xD;
Patient Pain&#xD;
Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.</description>
    <arm_group_label>C2 CryoBalloon Focal Ablation System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria Inclusion Criteria&#xD;
&#xD;
          -  Patients with known Barrett's esophagus, with an indication for ablation therapy&#xD;
             during which the cryoablation may be performed.&#xD;
&#xD;
          -  Patient is 18 to 80 years of age at the time of consent (inclusive).&#xD;
&#xD;
          -  Patient has provided written Informed Consent (IC) using an Informed Consent Form&#xD;
             (ICF) that has been approved by the Institution's reviewing IRB/EC.&#xD;
&#xD;
          -  Patient is willing and able to comply with all Clinical Investigation Plan (CIP)&#xD;
             requirements.&#xD;
&#xD;
          -  Patient is deemed operable per standard institutional criteria.&#xD;
&#xD;
          -  BE lesion length &lt;6cm excluding visible BE islands, and Prague Classification C ≥ 0 /&#xD;
             M ≥ 0.&#xD;
&#xD;
          -  One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions&#xD;
             (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly&#xD;
             differentiated, negative vertical (deep) resection margins, absence of&#xD;
             (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed&#xD;
             for indications listed above: i-iii)&#xD;
&#xD;
          -  BE lesion within the treatment zone should be flat&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of&#xD;
             treatment zone.&#xD;
&#xD;
          -  Patient has a known history of unresolved drug or alcohol dependency that would limit&#xD;
             ability to comprehend or follow instructions related to informed consent, post&#xD;
             treatment instructions or follow-up guidelines.&#xD;
&#xD;
          -  Patient refuses or is unable to provide written informed consent.&#xD;
&#xD;
          -  Patients that are pregnant.&#xD;
&#xD;
          -  Patient with endoscopically active inflammation in the treatment zone.&#xD;
&#xD;
          -  Endoscopically visible abnormalities such as masses or nodules requiring endoscopic&#xD;
             resection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques Bergman, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academic Medical Centre (Amsterdam)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academic Medical Center Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <results_reference>
    <citation>Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30.</citation>
    <PMID>21531411</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</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>Barrett Esophagus</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/NCT02249975
org study id: CP-0004.A
nct id: NCT02249975
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy and performance of the C2 Focal
      Cryoablation System in patients with BE.
The purpose of this study is to assess the efficacy and performance of the C2 Focal
      Cryoablation System in patients with BE. The study will involve up to 50 subjects with each
      subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation
      System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's
      epithelium with a maximal length of 6 cm.

      At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted
      for analysis according to Histopathology Protocol.

      This study is:

        -  Prospective

        -  Multi-center

        -  Non-randomized
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Presence of residual Barrett's Esophagus
time frame: 12 weeks
description: Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
measure: Incidence of adverse events
time frame: 12 weeks
description: All adverse events will be reported
measure: Patient Pain
time frame: post-procedure through 12 week follow-up
description: Patient is asked to rate any pain in the treatment area or with swallowing
measure: Device Performance
time frame: 12 weeks
description: All device performance will be reported
arm group label: C2 CryoBalloon Focal Ablation System
arm group type: Experimental
description: Cryoballoon ablation will be performed on patients with Barrett's Esophagus.
intervention type: Device
intervention name: C2 CryoBalloon Focal Ablation System
description: The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken.
Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.
Evaluations include, but are not limited to the following:
Device malfunctions
Adverse events
Patient Pain
Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus.
arm group label: C2 CryoBalloon Focal Ablation System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jacques Bergman, MD, PhD
role: Principal Investigator
affiliation: Academic Medical Centre (Amsterdam)
facility: 
facility: 
country: Netherlands
country: United Kingdom
citation: Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30.
PMID: 21531411
responsible party type: Sponsor
mesh term: Barrett Esophagus
sharing ipd: No