<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/NCT03023280</url>
  </required_header>
  <id_info>
    <org_study_id>1723/2015</org_study_id>
    <nct_id>NCT03023280</nct_id>
  </id_info>
  <brief_title>Radiofrequency Ablation in Patients With Large Cervical Heterotopic Gastric Mucosa and Globus Sensation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Ivan Kristo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be&#xD;
      present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus&#xD;
      sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard&#xD;
      treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to&#xD;
      concerns of stricture formation. Therefore, the investigators aimed to investigate the effect&#xD;
      of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the treatment&#xD;
      of large symptomatic CIP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Complete histologic eradication of heterotopic gastric mucosa</measure>
    <time_frame>measured endoscopically throughout the study period. First time point of measurement is 3 months after first ablation. Further measurements are carried out 3 months after subsequent ablations up to a maximum number of three ablations.</time_frame>
    <description>the change from gastric epithelium to squamous epithelium is monitored by histological sampling throughout the study period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>symptom assessment</measure>
    <time_frame>measured at the beginning, 12 weeks after first ablation and 12 weeks after final endoscopic examination</time_frame>
    <description>visual analog scale 0-10 (0=no interference, 10=maximum interference) is used for the symptom assessment of globus sensation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>laryngopharyngeal reflux</measure>
    <time_frame>at the beginning of the study period and 12 weeks after last endoscopic examination</time_frame>
    <description>the Reflux Finding Index is used for assessment of laryngopharyngeal reflux</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 quality of life</measure>
    <time_frame>at the beginning of the study (before ablations) and 12 weeks after final endoscopic examination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>adverse events are assessed within the first week after interventions</time_frame>
    <description>telephone calls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>laryngopharyngeal reflux II</measure>
    <time_frame>1 year after first ablation</time_frame>
    <description>the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux at the end of the study period</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Symptomatic Heterotopic Gastric Mucosa</condition>
  <arm_group>
    <arm_group_label>Patients undergoing radio frequency ablation</arm_group_label>
    <description>Patients undergoing radio frequency for large symptomatic heterotypic gastric mucosa</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency ablation</intervention_name>
    <arm_group_label>Patients undergoing radio frequency ablation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with macroscopic and histologic evidence of large (≥ 20mm diameter) heterotopic&#xD;
        gastric mucosa.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  negative PPI trial, ph-metry without correlation on globus sensation, prior&#xD;
             high-resolution manometry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not willing to participate in follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Dr. Ivan Kristo</investigator_full_name>
    <investigator_title>Dr.med.univ.</investigator_title>
  </responsible_party>
  <!-- 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/NCT03023280
org study id: 1723/2015
nct id: NCT03023280
lead sponsor: 
has dmc: No
Symptomatic heterotopic gastric mucosa also known as cervical inlet patch (CIP) may be
      present in varying shapes and causes symptoms of laryngopharyngeal reflux like globus
      sensations, hoarseness and chronic cough. Unfortunately, argon plasma coagulation, standard
      treatment of small symptomatic CIP, is limited for large heterotopic gastric mucosa due to
      concerns of stricture formation. Therefore, the investigators aimed to investigate the effect
      of radiofrequency ablation (RFA), a novel minimal-invasive ablation method, in the treatment
      of large symptomatic CIP.
observational model: Cohort
time perspective: Prospective
measure: Complete histologic eradication of heterotopic gastric mucosa
time frame: measured endoscopically throughout the study period. First time point of measurement is 3 months after first ablation. Further measurements are carried out 3 months after subsequent ablations up to a maximum number of three ablations.
description: the change from gastric epithelium to squamous epithelium is monitored by histological sampling throughout the study period
measure: symptom assessment
time frame: measured at the beginning, 12 weeks after first ablation and 12 weeks after final endoscopic examination
description: visual analog scale 0-10 (0=no interference, 10=maximum interference) is used for the symptom assessment of globus sensation
measure: laryngopharyngeal reflux
time frame: at the beginning of the study period and 12 weeks after last endoscopic examination
description: the Reflux Finding Index is used for assessment of laryngopharyngeal reflux
measure: SF-12 quality of life
time frame: at the beginning of the study (before ablations) and 12 weeks after final endoscopic examination
measure: number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: adverse events are assessed within the first week after interventions
description: telephone calls
measure: laryngopharyngeal reflux II
time frame: 1 year after first ablation
description: the Reflux Finding Score is measured by using laryngofibroscopy to document potential absence of laryngopharyngeal reflux at the end of the study period
arm group label: Patients undergoing radio frequency ablation
description: Patients undergoing radio frequency for large symptomatic heterotypic gastric mucosa
intervention type: Procedure
intervention name: Radiofrequency ablation
arm group label: Patients undergoing radio frequency ablation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Dr. Ivan Kristo
investigator title: Dr.med.univ.