<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/NCT04457193</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00164823</org_study_id>
    <nct_id>NCT04457193</nct_id>
  </id_info>
  <brief_title>Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus</brief_title>
  <official_title>Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Barrett's esophagus (BE) is a precancerous lesion characterized by the replacement of the&#xD;
      normal stratified squamous epithelium of the distal esophagus by intestinal metaplasia (IM).&#xD;
      Non-dysplastic BE may progress to low-grade dysplasia (LGD), to high-grade dysplasia (HGD)&#xD;
      and esophageal adenocarcinoma (EAC). Endoscopic ablation is safe and effective for complete&#xD;
      eradication of BE. However, recurrence is common. Cumulative incidence rate of BE recurrence&#xD;
      is up to 30% in the third year. Thus, achieving complete eradication of IM, patients should&#xD;
      undergo surveillance indefinitely with serial endoscopy to assess for recurrence of BE. In&#xD;
      addition, BE patients have been committed to life-long proton pump inhibitor (PPI) therapy,&#xD;
      but increasing concerns about adverse effects has led to alternative therapies. Studies have&#xD;
      showed that laparoscopic Nissen fundoplication may decrease recurrence of BE after endoscopic&#xD;
      ablation. Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that&#xD;
      mechanically creates fundoplication similar to traditional operative Nissen fundoplication.&#xD;
      The role of TIF in patients with BE whom underwent successful endoscopic ablation has not&#xD;
      been fully investigated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 7, 2018</start_date>
  <completion_date type="Anticipated">June 7, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 7, 2024</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>Percentage of participants with normal esophageal acid exposure time</measure>
    <time_frame>6 months</time_frame>
    <description>Normal esophageal acid exposure time is 6 percent or less.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants that are able to discontinue PPI post TIF</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of participants that are able to discontinue PPI post TIF will be assessed at 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of esophagitis post-TIF</measure>
    <time_frame>6 months</time_frame>
    <description>The presence of esophagitis on upper endoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with recurrence of BE and BE-related dysplasia</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Proportion of patients with recurrence of BE and BE-related dysplasia will be assessed up to 36 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of TIF-related serious adverse events</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Treatment related serious adverse events (SAEs) including hospitalization, unscheduled emergency room or physician visits for post-TIF symptoms), bloating, dysphagia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life as assessed by the GERD-Health-related quality of life Questionnaire</measure>
    <time_frame>Baseline, 6, 12, 24 and 36 months</time_frame>
    <description>The GERD-Health-related quality of life (HRQL) Questionnaire has an overall score range of 0 to 75. Each item is scored from 0 to 5, with a higher score indicating worse symptoms and poorer quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gastroesophageal Reflux Disease (GERD) symptoms assessed by the Reflux Symptom Index (RSI)</measure>
    <time_frame>Baseline, 6, 12, 24 and 36 months</time_frame>
    <description>The RSI is a nine-item self-administered outcome questionnaire designed to document reflux symptoms and severity. Each item is scored on a scale of 0 (no problem) to 5 (severe problem), with overall score ranging between 0 and 45. Higher scores mean more severe symptoms. RSI &gt; 13 may be indicative of significant reflux disease.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Barrett Esophagus</condition>
  <condition>Transoral Incisionless Fundoplication</condition>
  <arm_group>
    <arm_group_label>post-ablation Barrett's patients</arm_group_label>
    <description>The patients with known prior diagnosis of histologically-confirmed Barrett's esophagus with or without dysplasia who have documentation of complete remission of Barrett's esophagus by endoscopy and histology after endoscopic ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TIF</intervention_name>
    <description>Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that mechanically creates fundoplication similar to traditional operative Nissen fundoplication. The role of TIF in patients with BE whom underwent successful endoscopic ablation has not been fully investigated.</description>
    <arm_group_label>post-ablation Barrett's patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with history Barrett's esophagus who have resolution of Barrett's mucosa after&#xD;
        endoscopic ablation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 - 75 years&#xD;
&#xD;
          -  Known prior diagnosis of histologically-confirmed BE with or without dysplasia (as&#xD;
             defined by the presence of specialized columnar epithelium anywhere in the tubular&#xD;
             esophagus with &gt;= 1 cm of circumferential involvement or non-circumferential&#xD;
             involvement of specialized columnar epithelium) [Prague class &gt;1] and history of&#xD;
             initial complete eradication-IM following endoscopic ablation for Barrett's esophagus.&#xD;
&#xD;
          -  Documentation of complete ablation of BE by endoscopy and histology after&#xD;
             radiofrequency or cryotherapy ablation on two endoscopic examinations at least 3&#xD;
             months apart, within most recent endoscopy performed within 6 months. Pathologic&#xD;
             diagnosis determined by the expert pathologist at each site.&#xD;
&#xD;
          -  On PPI therapy, who opt for an intervention over lifelong drug dependence.&#xD;
&#xD;
          -  Hiatal hernia ≤ 2 cm or Hill grade &lt; 2 [unless patients undergoing combined TIF and&#xD;
             hiatal hernia repair]&#xD;
&#xD;
          -  Abnormal esophageal acid exposure [Percent esophageal acid exposure time &gt; 6% defined&#xD;
             by Bravo ph monitoring (48 - 96 hours study)&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 or &gt; 75 years&#xD;
&#xD;
          -  Inability to provide informed consent&#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>Saowanee Ngamruengphong</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saowanee Ngamruengphong</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 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>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/NCT04457193
org study id: IRB00164823
nct id: NCT04457193
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Barrett's esophagus (BE) is a precancerous lesion characterized by the replacement of the
      normal stratified squamous epithelium of the distal esophagus by intestinal metaplasia (IM).
      Non-dysplastic BE may progress to low-grade dysplasia (LGD), to high-grade dysplasia (HGD)
      and esophageal adenocarcinoma (EAC). Endoscopic ablation is safe and effective for complete
      eradication of BE. However, recurrence is common. Cumulative incidence rate of BE recurrence
      is up to 30% in the third year. Thus, achieving complete eradication of IM, patients should
      undergo surveillance indefinitely with serial endoscopy to assess for recurrence of BE. In
      addition, BE patients have been committed to life-long proton pump inhibitor (PPI) therapy,
      but increasing concerns about adverse effects has led to alternative therapies. Studies have
      showed that laparoscopic Nissen fundoplication may decrease recurrence of BE after endoscopic
      ablation. Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that
      mechanically creates fundoplication similar to traditional operative Nissen fundoplication.
      The role of TIF in patients with BE whom underwent successful endoscopic ablation has not
      been fully investigated.
observational model: Cohort
time perspective: Prospective
measure: Percentage of participants with normal esophageal acid exposure time
time frame: 6 months
description: Normal esophageal acid exposure time is 6 percent or less.
measure: Percentage of participants that are able to discontinue PPI post TIF
time frame: 6 months
description: Percentage of participants that are able to discontinue PPI post TIF will be assessed at 6 months.
measure: Incidence of esophagitis post-TIF
time frame: 6 months
description: The presence of esophagitis on upper endoscopy.
measure: Proportion of patients with recurrence of BE and BE-related dysplasia
time frame: Up to 36 months
description: Proportion of patients with recurrence of BE and BE-related dysplasia will be assessed up to 36 months.
measure: Number of TIF-related serious adverse events
time frame: Up to 36 months
description: Treatment related serious adverse events (SAEs) including hospitalization, unscheduled emergency room or physician visits for post-TIF symptoms), bloating, dysphagia.
measure: Change in quality of life as assessed by the GERD-Health-related quality of life Questionnaire
time frame: Baseline, 6, 12, 24 and 36 months
description: The GERD-Health-related quality of life (HRQL) Questionnaire has an overall score range of 0 to 75. Each item is scored from 0 to 5, with a higher score indicating worse symptoms and poorer quality of life.
measure: Change in Gastroesophageal Reflux Disease (GERD) symptoms assessed by the Reflux Symptom Index (RSI)
time frame: Baseline, 6, 12, 24 and 36 months
description: The RSI is a nine-item self-administered outcome questionnaire designed to document reflux symptoms and severity. Each item is scored on a scale of 0 (no problem) to 5 (severe problem), with overall score ranging between 0 and 45. Higher scores mean more severe symptoms. RSI > 13 may be indicative of significant reflux disease.
arm group label: post-ablation Barrett's patients
description: The patients with known prior diagnosis of histologically-confirmed Barrett's esophagus with or without dysplasia who have documentation of complete remission of Barrett's esophagus by endoscopy and histology after endoscopic ablation
intervention type: Device
intervention name: TIF
description: Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that mechanically creates fundoplication similar to traditional operative Nissen fundoplication. The role of TIF in patients with BE whom underwent successful endoscopic ablation has not been fully investigated.
arm group label: post-ablation Barrett's patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Saowanee Ngamruengphong
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Barrett Esophagus
sharing ipd: No