<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/NCT02211105</url>
  </required_header>
  <id_info>
    <org_study_id>AGA STAR Registry</org_study_id>
    <nct_id>NCT02211105</nct_id>
  </id_info>
  <brief_title>Registry to Compare Two Surgical Treatments for GERD</brief_title>
  <acronym>STAR Registry</acronym>
  <official_title>Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF): Anti- Reflux Treatment Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American Gastroenterological Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EndoGastric Solutions</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>American Gastroenterological Association</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective observational research study registry is to examine whether&#xD;
      two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless&#xD;
      Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side&#xD;
      effects and post-procedure costs associated with episodes of care and any ensuing&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This registry will prospectively enroll 500 patients undergoing TIF and LNF from&#xD;
      approximately 20 United States centers proficient in these procedures that have provided&#xD;
      informed consent for the above mentioned data collection (symptom questionnaires, medical&#xD;
      treatments, complications, side-effects and costs). The observational registry will obtain&#xD;
      the patients clinical data related to gastrointestinal symptoms for three years post-consent.&#xD;
&#xD;
      At baseline and for a three-year period following a clinically indicated TIF or LNF&#xD;
      procedure, data will be obtained from phone calls and/or during office-visits made at&#xD;
      specified intervals. During these data collection periods, patients will be asked to complete&#xD;
      standard validated symptom questionnaires as well as report on episodes of care related to&#xD;
      their procedures along with financial costs of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unexpected low accrual&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Effectiveness as measured by a 75% reduction in GERD HRQL)</measure>
    <time_frame>3 years</time_frame>
    <description>To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness using a 50% reduction in GERD-HRQL</measure>
    <time_frame>3 years</time_frame>
    <description>Compare effectiveness using a 50% reduction in GERD-HRQL as a threshold for effectiveness of TIF and LNF at the end of three years compared to baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Durability of GERD surgeries</measure>
    <time_frame>1 year and 3 years</time_frame>
    <description>Compare the durability of TIF to LNF by determining the proportion of patients that achieve either a) &gt;75% or b) &gt;50% within the first year that maintain this effect at three years</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of TIF to LNF for Patient reported symptoms</measure>
    <time_frame>3 years</time_frame>
    <description>Compare TIF to LNF with respect to other reported GI symptoms, complications and side effects.</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of Post-Procedure cost</measure>
    <time_frame>3 years</time_frame>
    <description>Estimate the post-procedure costs associated with episodes of care and any ensuing complications or side effects of TIF and LNF.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>GastroEsophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Laparoscopic Nissen Fundoplication</arm_group_label>
    <description>Patients whose GERD is being treated surgically through Laparoscopic Nissen Fundoplication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transoral Incisionless Fundoplication</arm_group_label>
    <description>Patients whose GERD is being treated surgically through Transoral Incisionless Fundoplication.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults who meet clinical criteria and have decided to treat their GERD through one of two&#xD;
        surgical procedures, (LNF or TIF) and agree to have their standard GI medical data for 3&#xD;
        years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  GERD symptoms (heartburn, defined by a sub-sternal burning discomfort arising from the&#xD;
             upper abdomen into the chest, and or regurgitation, defined as the effortless arising&#xD;
             of liquid material into the chest or mouth) two or more times a week (when not on&#xD;
             anti-secretory medication) that adversely affects the patient's quality of life.&#xD;
             Additionally, patients will have to have responded to medical therapy (adequate relief&#xD;
             of symptoms) as indicated by GERD-HRQL and regurgitation scores on medical therapy. In&#xD;
             this context, scores ≤ 2 on each GERD-HRQL and regurgitation question (while on&#xD;
             medication) indicate absence of daily bothersome symptoms and therefore these patients&#xD;
             are considered responsive to medical therapy. Furthermore, patients will have to have&#xD;
             objective evidence of GERD documented (esophagitis on endoscopy or pathological&#xD;
             intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring).&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Regular access to a telephone&#xD;
&#xD;
          -  Meet the clinical criteria for treatment of GERD with TIF or LNF and undergo TIF or&#xD;
             LNF within 90 days of providing consent.&#xD;
&#xD;
               -  Dependent upon PPIs for control of heartburn for &gt; six months or patient&#xD;
                  determined to have an inadequate response of regurgitation symptoms despite&#xD;
                  heartburn control with PPIs&#xD;
&#xD;
               -  Hiatal hernia axial length is no larger than 2 cm and the transverse dimension&#xD;
                  should not exceed 2.0 cm&#xD;
&#xD;
               -  Gastroesophageal junction with a Hill Grade I-II&#xD;
&#xD;
                  --- Patient willing to provide informed consent, cooperate with post-operative&#xD;
                  dietary recommendations and follow-up assessment tests&#xD;
&#xD;
               -  Objective documentation of pathological acid-reflux by either a) increased&#xD;
                  intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring&#xD;
                  (pH&lt;4 for 4.5% or greater of the time) with or without impedance b) or the&#xD;
                  presence of erosive esophagitis (LA Grade A or B) on endoscopy&#xD;
&#xD;
               -  Absence of a severe esophageal motility disorder (note: mild abnormalities in&#xD;
                  esophageal motility are common in GERD such as small breaks, etc.) including&#xD;
                  achalasia, esophagogastric junction outflow obstruction, frequent failed&#xD;
                  peristalsis, diffuse esophageal spasm, nutcracker or jackhammer esophagus etc. on&#xD;
                  high-resolution esophageal manometry using the Chicago classification system or&#xD;
                  evidence of incomplete bolus clearance on 30% or more of swallows by impedance&#xD;
                  testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hiatal hernia &gt; 2 cm (defined as longitudinal length measured endoscopically between&#xD;
             the proximal margin of the gastric folds and the diaphragmatic pinch)&#xD;
&#xD;
          -  Esophagitis LA Grade C or D&#xD;
&#xD;
          -  Presence of troublesome atypical symptoms&#xD;
&#xD;
          -  Barrett's esophagus greater than 2 cm in length or with any dysplasia&#xD;
&#xD;
          -  Esophageal stricture or severe esophageal motility disorder&#xD;
&#xD;
          -  History of previous resective gastric or esophageal surgery, cervical spine fusion,&#xD;
             Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or&#xD;
             dermatomyositis, eosinophilic esophagitis, cirrhosis or any other uncontrolled&#xD;
             systemic disease&#xD;
&#xD;
             --. Active gastro-duodenal ulcer disease&#xD;
&#xD;
          -  Gastric outlet obstruction or stenosis&#xD;
&#xD;
          -  Gastroparesis or delayed gastric emptying confirmed by a four hour solid-phase gastric&#xD;
             emptying study&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 35&#xD;
&#xD;
          -  Pregnancy or plans for pregnancy within 12 months of the procedure&#xD;
&#xD;
          -  Portal hypertension and/or varices&#xD;
&#xD;
          -  New York Heart Association classification of III or IV.&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  Intraprocedural determination of anatomical presentation which in the opinion of the&#xD;
             surgeon does not allow safe performance of the procedure&#xD;
&#xD;
          -  Enrollment in another device or drug study that may confound result&#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>M. Brian Fennerty, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>W. Scott Melvin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ashish Atreja, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OC Reflux</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SurgOne Foregut Institute</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Solutions Inc</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239-3098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas at Houston</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reston Hospital Center/ GW University</name>
      <address>
        <city>Reston</city>
        <state>Virginia</state>
        <zip>20190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GastroEsophageal Reflux Disease</keyword>
  <keyword>Transoral Incisionless Fundoplication</keyword>
  <keyword>Laparoscopic Nissen Fundoplication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</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/NCT02211105
org study id: AGA STAR Registry
nct id: NCT02211105
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this prospective observational research study registry is to examine whether
      two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless
      Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side
      effects and post-procedure costs associated with episodes of care and any ensuing
      complications.
This registry will prospectively enroll 500 patients undergoing TIF and LNF from
      approximately 20 United States centers proficient in these procedures that have provided
      informed consent for the above mentioned data collection (symptom questionnaires, medical
      treatments, complications, side-effects and costs). The observational registry will obtain
      the patients clinical data related to gastrointestinal symptoms for three years post-consent.

      At baseline and for a three-year period following a clinically indicated TIF or LNF
      procedure, data will be obtained from phone calls and/or during office-visits made at
      specified intervals. During these data collection periods, patients will be asked to complete
      standard validated symptom questionnaires as well as report on episodes of care related to
      their procedures along with financial costs of care.
observational model: Case-Control
time perspective: Prospective
measure: Effectiveness as measured by a 75% reduction in GERD HRQL)
time frame: 3 years
description: To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.
measure: Effectiveness using a 50% reduction in GERD-HRQL
time frame: 3 years
description: Compare effectiveness using a 50% reduction in GERD-HRQL as a threshold for effectiveness of TIF and LNF at the end of three years compared to baseline.
measure: Durability of GERD surgeries
time frame: 1 year and 3 years
description: Compare the durability of TIF to LNF by determining the proportion of patients that achieve either a) >75% or b) >50% within the first year that maintain this effect at three years
measure: Comparison of TIF to LNF for Patient reported symptoms
time frame: 3 years
description: Compare TIF to LNF with respect to other reported GI symptoms, complications and side effects.
measure: Comparison of Post-Procedure cost
time frame: 3 years
description: Estimate the post-procedure costs associated with episodes of care and any ensuing complications or side effects of TIF and LNF.
arm group label: Laparoscopic Nissen Fundoplication
description: Patients whose GERD is being treated surgically through Laparoscopic Nissen Fundoplication.
arm group label: Transoral Incisionless Fundoplication
description: Patients whose GERD is being treated surgically through Transoral Incisionless Fundoplication.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: M. Brian Fennerty, M.D.
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: W. Scott Melvin, M.D.
role: Principal Investigator
affiliation: Montefiore Medical Center
last name: Ashish Atreja, M.D.
role: Study Chair
affiliation: MOUNT SINAI HOSPITAL
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux