<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/NCT01661608</url>
  </required_header>
  <id_info>
    <org_study_id>TPR41122</org_study_id>
    <nct_id>NCT01661608</nct_id>
  </id_info>
  <brief_title>Gastric Restriction Using the EndoSurgical Operating System</brief_title>
  <official_title>Gastric Restriction Using the EndoSurgical Operating System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>USGI Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>USGI Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to collect data on the use of the EndoSurgical Operating System&#xD;
      (EOS) for gastric tissue approximation during primary gastric restrictive procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    FDA indicated study should have had prior IDE submission &amp; approval&#xD;
  </why_stopped>
  <start_date>December 2008</start_date>
  <completion_date type="Actual">January 2010</completion_date>
  <primary_completion_date type="Actual">January 2010</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Evaluation in regards to Weight Loss</measure>
    <time_frame>24 Months Post-op</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>EOS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Collecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Using the EOS for gastric restriction</intervention_name>
    <arm_group_label>EOS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has met diabetic lab testing and all pre-procedural qualifications as&#xD;
             delineated below.&#xD;
&#xD;
          -  Patient is &gt;/= 20 yrs. of age and &lt;/= 60 yrs. of age&#xD;
&#xD;
          -  Patient has a BMI of &gt;/=30 and &lt; 40&#xD;
&#xD;
          -  Patient has history of obesity for &gt;/= 2 yrs.&#xD;
&#xD;
          -  Patient has had not significant weight change (&lt;5% of total body weight) in last 6&#xD;
             months.&#xD;
&#xD;
          -  Patient is a reasonable candidate for general anesthesia&#xD;
&#xD;
          -  Patient agrees not to have any additional weight loss surgery or liposuction for 2&#xD;
             yrs. following procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is not able and willing to return for all follow-up evaluations, tests and&#xD;
             nutritional counseling.&#xD;
&#xD;
          -  Patient is not able to provide written informed consent&#xD;
&#xD;
          -  Patient has history or present use of insulin or insulin derivatives for treatment of&#xD;
             diabetes.&#xD;
&#xD;
          -  Patient has diabetes secondary to a specific disease.&#xD;
&#xD;
          -  Patient has history of inflammatory disease of GI tract&#xD;
&#xD;
          -  Patient has diabetic retinopathy&#xD;
&#xD;
          -  Patient has chronic pancreatic disease&#xD;
&#xD;
          -  Patient ahs active peptic ulcer&#xD;
&#xD;
          -  Patient has portal hypertension&#xD;
&#xD;
          -  Patient has esophageal varices&#xD;
&#xD;
          -  Patient has significant esophageal disease&#xD;
&#xD;
          -  Patient has a history of any significant abdominal surgery&#xD;
&#xD;
          -  Patient has a history of any bariatric or GERD surgical procedures&#xD;
&#xD;
          -  Patient has a hiatal hernia &gt; 2cm.&#xD;
&#xD;
          -  Patient has esophageal stricture or other anatomy and/or condition that could preclude&#xD;
             passage of endolumenal instruments&#xD;
&#xD;
          -  Patient is of childbearing age and not practicing effective birth control method,&#xD;
             pregnant or lactating.&#xD;
&#xD;
          -  Patient has had a MI or CVA in last year, or has unstable cardiovascular disease.&#xD;
&#xD;
          -  Patient has cancer or life expectancy of &lt; 2 yrs.&#xD;
&#xD;
          -  Patient currently uses or has used over the counter or prescription weight loss drugs&#xD;
             in last month or intends to use during follow-up Registry period.&#xD;
&#xD;
          -  Patient has quit smoking within last 6 months or plans to quit smoking in the next&#xD;
             year.&#xD;
&#xD;
          -  Patient has a history of durg or alcohol abuse&#xD;
&#xD;
          -  Patient has uncontrolled depression, psychosis, or eating disorder.&#xD;
&#xD;
          -  Patient is non-ambulatory or has significant impairment of mobility.&#xD;
&#xD;
          -  Patient has known hormonal or genetic cause for obesity.&#xD;
&#xD;
          -  Patient is participating in another Registry and/or Study that could adversely affect&#xD;
             this Registry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J. Thomas, MD, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>SSL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Lavin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SSL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Voelinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Presbyterian</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Denk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bluegrass</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christopher Thompson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham &amp; Womans</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Santiago Horgan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bluegrass</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SSL</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Womens</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mexico</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric Restriction</keyword>
  <!-- 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/NCT01661608
org study id: TPR41122
nct id: NCT01661608
lead sponsor: 
has dmc: Yes
The primary objective is to collect data on the use of the EndoSurgical Operating System
      (EOS) for gastric tissue approximation during primary gastric restrictive procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Clinical Evaluation in regards to Weight Loss
time frame: 24 Months Post-op
arm group label: EOS
arm group type: Experimental
description: Collecting data on the use of the EOS for gastric tissue approximation during primary gastric restrictive procedures
intervention type: Device
intervention name: Using the EOS for gastric restriction
arm group label: EOS
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael J. Thomas, MD, FACS
role: Principal Investigator
affiliation: SSL
last name: Thomas Lavin, MD
role: Principal Investigator
affiliation: SSL
last name: David Voelinger, MD
role: Principal Investigator
affiliation: Presbyterian
last name: Peter Denk, MD
role: Principal Investigator
affiliation: Bluegrass
last name: Christopher Thompson, MD
role: Principal Investigator
affiliation: Brigham & Womans
last name: Santiago Horgan, MD
role: Principal Investigator
affiliation: UCSD
facility: 
facility: 
facility: 
facility: 
facility: 
country: Mexico
country: United States
responsible party type: Sponsor