<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/NCT02231970</url>
  </required_header>
  <id_info>
    <org_study_id>657-GHM</org_study_id>
    <nct_id>NCT02231970</nct_id>
  </id_info>
  <brief_title>Endoscopic Sleeve Gastroplasty for Treatment of Obesity</brief_title>
  <official_title>Endoscopic Sleeve Gastroplasty for Treatment of Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo Hospital de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grupo Hospital de Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations&#xD;
      achieved by surgical sleeve gastrectomy.&#xD;
&#xD;
      The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the&#xD;
      treatment of patients with obesity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a&#xD;
      cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up&#xD;
      by a nutritionist and a psychologist weekly.The outcome assessment included: change in body&#xD;
      weight, percentage of loss of excess body weight and adverse effects&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Change in body weight</measure>
    <time_frame>One year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>One year</time_frame>
    <description>Any complications following the intervention like abdominal pain or bleeding</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Percentage of excess weight loss</measure>
    <time_frame>One year</time_frame>
    <description>Percentage of excess weight loss defined as the percentage of weight loss in relation with initial weight minus weight at BMI of 25 kg/m2</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Endoscopic sleeve gastroplasty</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is an endoscopic procedure: to perform endoscopic sleeve gastroplasty we used a cap-based flexible endoscopic suturing system (OverStitch™, Apollo, Inc. Austin, Texas) mounted on a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corporation, Tokyo, Japan) to achieve full-thickness, running sutures through the gastric wall from antrum to fundus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic sleeve gastroplasty</intervention_name>
    <description>To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty</description>
    <arm_group_label>Endoscopic sleeve gastroplasty</arm_group_label>
    <other_name>ESG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Obesity Willingness and ability of patients to be treated by a multidisciplinary team for&#xD;
        at least 1 year -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and&#xD;
        neoformative findings ) Coagulopathy Psychiatric disorders&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GONTRAND LOPEZ-NAVA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOSPITAL UNIVERSITARIO SANCHINARRO</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>GONTRAND LOPEZ-NAVA, MD</last_name>
    <phone>+34917567800</phone>
    <email>gontrandlopeznava@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>INMACULADA BAUTISTA-CASTAÑO, MD, PHD</last_name>
    <phone>+34917567800</phone>
    <email>inmaculadabautista60@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario Sanchinarro</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>GONTRAND LOPEZ-NAVA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 4, 2014</last_update_submitted>
  <last_update_submitted_qc>September 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Grupo Hospital de Madrid</investigator_affiliation>
    <investigator_full_name>Sofia Perea, Director Clinical Trials Unit.</investigator_full_name>
    <investigator_title>Director, Clinical Trial Unit</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Endoscopic sleeve gastroplasty</keyword>
  <keyword>Weight loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT02231970
org study id: 657-GHM
nct id: NCT02231970
lead sponsor: 
has dmc: No
Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations
      achieved by surgical sleeve gastrectomy.

      The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the
      treatment of patients with obesity
The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a
      cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up
      by a nutritionist and a psychologist weekly.The outcome assessment included: change in body
      weight, percentage of loss of excess body weight and adverse effects
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in body weight
time frame: One year
measure: Safety
time frame: One year
description: Any complications following the intervention like abdominal pain or bleeding
measure: Percentage of excess weight loss
time frame: One year
description: Percentage of excess weight loss defined as the percentage of weight loss in relation with initial weight minus weight at BMI of 25 kg/m2
arm group label: Endoscopic sleeve gastroplasty
arm group type: Experimental
description: The intervention is an endoscopic procedure: to perform endoscopic sleeve gastroplasty we used a cap-based flexible endoscopic suturing system (OverStitch™, Apollo, Inc. Austin, Texas) mounted on a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corporation, Tokyo, Japan) to achieve full-thickness, running sutures through the gastric wall from antrum to fundus.
intervention type: Procedure
intervention name: Endoscopic sleeve gastroplasty
description: To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty
arm group label: Endoscopic sleeve gastroplasty
other name: ESG
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: GONTRAND LOPEZ-NAVA, MD
role: Principal Investigator
affiliation: HOSPITAL UNIVERSITARIO SANCHINARRO
last name: GONTRAND LOPEZ-NAVA, MD
phone: +34917567800
email: gontrandlopeznava@gmail.com
last name: INMACULADA BAUTISTA-CASTAÑO, MD, PHD
phone: +34917567800
email: inmaculadabautista60@gmail.com
facility: 
status: Recruiting
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Grupo Hospital de Madrid
investigator full name: Sofia Perea, Director Clinical Trials Unit.
investigator title: Director, Clinical Trial Unit
mesh term: Obesity