<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/NCT01682265</url>
  </required_header>
  <id_info>
    <org_study_id>BRD/11/06-Q</org_study_id>
    <nct_id>NCT01682265</nct_id>
  </id_info>
  <brief_title>Stretta In Reflux Uncontrolled by IPP</brief_title>
  <acronym>SIRUP</acronym>
  <official_title>Stretta In Reflux Uncontrolled by Intake of Inhibitors of Protons Pump (IPP).- The SIRUP Trial- Multicentric, Randomized, Double Blind, Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency&#xD;
      6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP)&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is over a period of 1 year. After checking eligibility, the patient will be&#xD;
      randomised in double blind : stretta procedure /sham procedure. Control visits will take&#xD;
      place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and&#xD;
      24 weeks(on site).During the 24 weeks visit, the therapeutic success will be evaluated.&#xD;
&#xD;
      In case of success, endoscopic control will be performed and the patient will come back on&#xD;
      site at week 36 and 48 (end of study). In case of therapeutic failure, the stretta procedure&#xD;
      will be proposed to the patient without breaking the blind for the 1st procedure. The&#xD;
      procedure will be scheduled between week 24 and week 27. The patient will come back for a&#xD;
      visit on site at weeks 31, 36 and 48 (end of visit)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2012</start_date>
  <completion_date type="Actual">November 27, 2018</completion_date>
  <primary_completion_date type="Actual">November 27, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficiency of the treatment 6 months post-procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate the efficiency of the treatment 6 months post-procedure according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 24</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects on digestive symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Compare Stretta and sham procedure according to complete relief of digestive symptoms and pyrosis (calculation based upon number of days without digestive symptoms and pyrosis as indicated by the patient on a questionary completed during the 2 weeks preceding visits à 6 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects on digestive symptoms</measure>
    <time_frame>1 year</time_frame>
    <description>Compare Stretta and sham procedure according to complete relief of digestive symptoms and pyrosis (calculation based upon number of days without digestive symptoms and pyrosis as indicated by the patient on a questionary completed during the 2 weeks preceding visits à 12 months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necessity of IPP treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Compare Stretta and sham procedure according to necessity of IPP treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>necessity of IPP treatment</measure>
    <time_frame>1 year</time_frame>
    <description>Compare Stretta and sham procedure according to necessity of IPP treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance</measure>
    <time_frame>6 months</time_frame>
    <description>Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance</measure>
    <time_frame>1 year</time_frame>
    <description>Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of live</measure>
    <time_frame>6 months</time_frame>
    <description>Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Compare Stretta and sham procedure according to Quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH-impedancemetry predictive factors</measure>
    <time_frame>At Inclusion</time_frame>
    <description>pH-impedancemetry will be realized at clinical trial start, when patient is under PPI intake to determine pH-impedancemetry predictive factors for positive response to stretta method. Acid and non acid exposition of the esophagus will be measured as well as the SAP (Symptom Association Probability) which corresponds to the probability of association between symptoms felt by the patient during the pH-impedancemetry and episodes of acid or non acid reflux.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficiency</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate efficiency of the stretta procedure in patients unsatisfied after the sham procedure at week 48 according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 48</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficiency</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate efficiency of the 2nd stretta procedure in patients unsatisfied after the 1st stretta procedure at week 48 according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 48</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Stretta procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient randomized in Stretta procedure arm will be hospitalized to have endoscopy and esophagus will receive radiofrequency.&#xD;
Control visits will then take place until Month 6. At this visit endoscopic control will take place.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham procedure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patient randomized in Sham procedure arm will be hospitalized to have endoscopy. Material necessary to perform Stretta procedure will be inserted (like in Stretta procedure arm) BUT esophagus will not receive radiofrequency.&#xD;
Control visits will then take place until Month 6. At this visit endoscopic control will take place.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stretta procedure</intervention_name>
    <arm_group_label>Stretta procedure</arm_group_label>
    <other_name>Radiofrequency of esophagus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham procedure</intervention_name>
    <description>No radiofrequency delivered</description>
    <arm_group_label>Sham procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 ans&#xD;
&#xD;
          -  Severe or moderate heartburn (at least 3 heartburn times per week), persistent under&#xD;
             treatment with IPP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent oeso-gastro-duodenal endoscopy(&lt; 3 months)&#xD;
&#xD;
          -  Oesophagitis &gt; grade A&#xD;
&#xD;
          -  Endobrachyoesophagus &gt; C0M1&#xD;
&#xD;
          -  Hiatal Hernia &gt; 2 cm&#xD;
&#xD;
          -  Symptoms insufficiently relieved with continued intake of IPP or with intake of IPP&#xD;
             according to needs&#xD;
&#xD;
          -  Predominant symptom of Gastrooesophageal reflux disease other than heartburn&#xD;
&#xD;
          -  Patients contra-indicated for radiofrequency technique&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stanislas Bruley des Varannes, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes Universitary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chloe Melchior, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen Universitary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thierry Ponchon, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lyon Universitary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Franck Zerbib, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bordeaux Universitary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Franck Cholet, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brest Universitary hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benoit Coffin, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP-Louis Mourier hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nantes Universitary Hospital</name>
      <address>
        <city>Nantes</city>
        <state>Loire Atlantique</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bordeaux Universitary Hospital</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brest universitary hospital</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Louis Mourier hospital</name>
      <address>
        <city>Colombes</city>
        <zip>92700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyon Universitary Hospital</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rouen Universitary Hospital</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</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>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/NCT01682265
org study id: BRD/11/06-Q
nct id: NCT01682265
lead sponsor: 
has dmc: Yes
The aim of the study is to compare the Stretta procedure and the Sham procedure efficiency
      6months post-procedure in reflux uncontrolled by intake of Inhibitors of Protons Pump (IPP)
      patients.
The study is over a period of 1 year. After checking eligibility, the patient will be
      randomised in double blind : stretta procedure /sham procedure. Control visits will take
      place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and
      24 weeks(on site).During the 24 weeks visit, the therapeutic success will be evaluated.

      In case of success, endoscopic control will be performed and the patient will come back on
      site at week 36 and 48 (end of study). In case of therapeutic failure, the stretta procedure
      will be proposed to the patient without breaking the blind for the 1st procedure. The
      procedure will be scheduled between week 24 and week 27. The patient will come back for a
      visit on site at weeks 31, 36 and 48 (end of visit)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Efficiency of the treatment 6 months post-procedure
time frame: 6 months
description: Evaluate the efficiency of the treatment 6 months post-procedure according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 24
measure: Effects on digestive symptoms
time frame: 6 months
description: Compare Stretta and sham procedure according to complete relief of digestive symptoms and pyrosis (calculation based upon number of days without digestive symptoms and pyrosis as indicated by the patient on a questionary completed during the 2 weeks preceding visits à 6 months)
measure: Effects on digestive symptoms
time frame: 1 year
description: Compare Stretta and sham procedure according to complete relief of digestive symptoms and pyrosis (calculation based upon number of days without digestive symptoms and pyrosis as indicated by the patient on a questionary completed during the 2 weeks preceding visits à 12 months)
measure: Necessity of IPP treatment
time frame: 6 months
description: Compare Stretta and sham procedure according to necessity of IPP treatment
measure: necessity of IPP treatment
time frame: 1 year
description: Compare Stretta and sham procedure according to necessity of IPP treatment
measure: Tolerance
time frame: 6 months
description: Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 24.
measure: Tolerance
time frame: 1 year
description: Compare Stretta and sham procedure according to Tolerance analysed by recording of adverse events (sides effects of each procedure) until week 48.
measure: Quality of live
time frame: 6 months
description: Compare Stretta and sham procedure according to Quality of life (use of quality of life questionaries)
measure: Quality of life
time frame: 1 year
description: Compare Stretta and sham procedure according to Quality of life
measure: pH-impedancemetry predictive factors
time frame: At Inclusion
description: pH-impedancemetry will be realized at clinical trial start, when patient is under PPI intake to determine pH-impedancemetry predictive factors for positive response to stretta method. Acid and non acid exposition of the esophagus will be measured as well as the SAP (Symptom Association Probability) which corresponds to the probability of association between symptoms felt by the patient during the pH-impedancemetry and episodes of acid or non acid reflux.
measure: Efficiency
time frame: 1 year
description: Evaluate efficiency of the stretta procedure in patients unsatisfied after the sham procedure at week 48 according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 48
measure: Efficiency
time frame: 1 year
description: Evaluate efficiency of the 2nd stretta procedure in patients unsatisfied after the 1st stretta procedure at week 48 according to the patient's answers to the 2 following items : IPP treatment taken less than 7 days /week and adequate relief of symptoms. These results will be completed by the patient on a calendar during 2 weeks before the visit week 48
arm group label: Stretta procedure
arm group type: Experimental
description: Patient randomized in Stretta procedure arm will be hospitalized to have endoscopy and esophagus will receive radiofrequency.
Control visits will then take place until Month 6. At this visit endoscopic control will take place.
arm group label: Sham procedure
arm group type: Sham Comparator
description: Patient randomized in Sham procedure arm will be hospitalized to have endoscopy. Material necessary to perform Stretta procedure will be inserted (like in Stretta procedure arm) BUT esophagus will not receive radiofrequency.
Control visits will then take place until Month 6. At this visit endoscopic control will take place.
intervention type: Other
intervention name: Stretta procedure
arm group label: Stretta procedure
other name: Radiofrequency of esophagus
intervention type: Other
intervention name: Sham procedure
description: No radiofrequency delivered
arm group label: Sham procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stanislas Bruley des Varannes, Professor
role: Principal Investigator
affiliation: Nantes Universitary Hospital
last name: Chloe Melchior, Doctor
role: Principal Investigator
affiliation: Rouen Universitary Hospital
last name: Thierry Ponchon, Professor
role: Principal Investigator
affiliation: Lyon Universitary Hospital
last name: Franck Zerbib, Professor
role: Principal Investigator
affiliation: Bordeaux Universitary Hospital
last name: Franck Cholet, Doctor
role: Principal Investigator
affiliation: Brest Universitary hospital
last name: Benoit Coffin, Professor
role: Principal Investigator
affiliation: APHP-Louis Mourier hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux