<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/NCT01679158</url>
  </required_header>
  <id_info>
    <org_study_id>TPR600</org_study_id>
    <nct_id>NCT01679158</nct_id>
  </id_info>
  <brief_title>MOTIVATE Weight Loss Study</brief_title>
  <acronym>MOTIVATE</acronym>
  <official_title>Evaluating MOTIlity, Hormonal Impact, Satiety, and Weight Changes With VArying Procedural TEchniques Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity</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 purpose of this study is to evaluate the impact of minor variations in Incisionless&#xD;
      Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety,&#xD;
      and weight loss in the treatment of primary obesity. It will confirm, in an open prospective&#xD;
      study, the action mechanisms for the &quot;POSE&quot; endoscopic treatment technique for obesity, and&#xD;
      it will help determine if they are maintained at least 6 months following the procedure.&#xD;
      Durability of weight loss will be tracked through post-POSE visits up to 18 months following&#xD;
      the procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>Monthly post procedure out to 18 months</time_frame>
    <description>Each patient's weight will be measured and recorded on a monthly basis out to 18 months post procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting/Post-prandial Peptides</measure>
    <time_frame>pre-procedure &amp; 8 weeks post procedure</time_frame>
    <description>Samples to be collected when fasting and 30, 60, 90, and 120 minutes after a standard meal (a meal consisting of 400 calories), The meal must be consumed within 10 minutes.. Serum collection tubes will be centrifuged immediately at 4°C for 10 minutes at 3600rpm and stored at -20°C&#xD;
Samples to be collected by ELISA are: C-peptide, serum insulin, glucose, PYY, GLP-1 (active), leptin, and GIP. Total ghrelin level to be analyzed by RIA.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Gastric Emptying</measure>
    <time_frame>Pre-procedure &amp; 2 &amp; 6 months post procedure</time_frame>
    <description>This test consists of determining the duration of a radioactive marker in a stomach, which is non-absorbable, and free of any food components.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satiety Testing</measure>
    <time_frame>Pre-procedure &amp; 2 &amp; 6 months post procedure</time_frame>
    <description>The subjects ingest a nutritional drink (Ensure) at a constant rate of 30 mL per minute, constantly filling the glass with a perfusion pump (Gemini PC-2, IMED, San Diego, CA). (The subjects are not conscious of the volume being ingested.) The subjects are instructed to maintain consumption at the fill rate. Participants take note of their sensation of satiety with a graphical classification scale, which combines verbal descriptors on a scale of 0 to 5 (0 = no symptoms, 1 = first sensation of fullness [threshold]; 2 = light, 3 = moderate, 4 = severe, and 5 = maximum fullness or unbearable). The participants are told to stop taking the food product when a score of 5 is obtained. The maximum consumption of volume of the nutritional drink is recorded.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Continuous Horizontal row</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reduction in &quot;ring&quot; opening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use the IOP system from USGI to install suture anchors to reduce the &quot;ring&quot; opening to the antrum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use the IOP system from USGI to install suture anchors in the Current V shape in distal body</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Using The IOP system from USGI to place suture anchors</intervention_name>
    <description>Sutures are placed in the distal body in one of three randomized techniques:&#xD;
&quot;A&quot; = reduction in &quot;ring&quot; opening to antrum using plications &quot;B&quot; = continuous horizontal row, running from distal body into proximal antrum &quot;C&quot; = Control. Current V shape as Control</description>
    <arm_group_label>Continuous Horizontal row</arm_group_label>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Reduction in &quot;ring&quot; opening</arm_group_label>
    <other_name>The g-Cath EZ Suture Anchor Delivery Catheter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has a BMI of &gt;30 and &lt;40&#xD;
&#xD;
          2. Male or female ≥21 yrs. of age and &lt; 60 yrs. of age at time of enrollment&#xD;
&#xD;
          3. Patient has had no significant weight change (+/- 5% of total body weight) in last 6&#xD;
             months but has been able to lose significant weight in the past with diet and&#xD;
             exercise.&#xD;
&#xD;
          4. Is a reasonable candidate for general anesthesia&#xD;
&#xD;
          5. Agrees not to have any additional weight loss interventional procedures or liposuction&#xD;
             for at least 18 months following study enrollment and agrees not to take any&#xD;
             prescription or over the counter weight loss medications for at least 1 year.&#xD;
&#xD;
          6. Physically and mentally able to comply with the visit schedule, ancillary testing, and&#xD;
             behavior modification (diet and exercise) required for the study and agrees to study&#xD;
             commitment requirements&#xD;
&#xD;
          7. Had successful completion of the pre-screening, nutritional and educational programs&#xD;
             and psychological assessment supporting that the subject is an appropriate bariatric&#xD;
             surgical candidate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of (or intra-operative evidence of) bariatric, gastric or esophageal surgery&#xD;
&#xD;
          2. Esophageal stricture or other anatomy and/or condition that could preclude passage of&#xD;
             endoluminal instruments&#xD;
&#xD;
          3. Moderate to severe Gastro-esophageal reflux disease (GERD)&#xD;
&#xD;
          4. Known hiatal hernia &gt;3cm by history or as determined by UGI exam or endoscopy&#xD;
&#xD;
          5. Known GI motility disorder or pancreatic insufficiency/disease&#xD;
&#xD;
          6. Intra-operative Exclusion: Active peptic ulcer or hiatal hernia &gt;3cm&#xD;
&#xD;
          7. Pregnancy.&#xD;
&#xD;
          8. Present Corticosteroid Use&#xD;
&#xD;
          9. History of inflammatory disease of GI tract&#xD;
&#xD;
         10. Severe coagulopathies, hepatic insufficiency or cirrhosis&#xD;
&#xD;
         11. History or present use of insulin or insulin derivatives for treatment of diabetes&#xD;
&#xD;
         12. Had Type II Diabetes Mellitus (as defined by HgbA1c &gt;6.0) for greater than 2 years at&#xD;
             the time of enrollment&#xD;
&#xD;
         13. Uncontrolled Type II DM (HgbA1c &gt;7.0 at screening)&#xD;
&#xD;
         14. Patient has quit smoking within last 6 months at time of enrollment or plans to quit&#xD;
             smoking in the next year&#xD;
&#xD;
         15. Patient has a history of drug or alcohol abuse or actively abusing either&#xD;
&#xD;
         16. Patient is presently being treated with medication for depression, psychosis, or other&#xD;
             mood or eating disorder&#xD;
&#xD;
         17. Non-ambulatory or has significant impairment of mobility&#xD;
&#xD;
         18. Works for, or is first degree relative of investigator, study institution, or support&#xD;
             staff involved in the study.&#xD;
&#xD;
         19. Known hormonal or genetic cause for obesity&#xD;
&#xD;
         20. Participating in another clinical study&#xD;
&#xD;
         21. Patient is on medications known to impact GI motility or gut hormones that cannot be&#xD;
             discontinued prior to nuclear testing&#xD;
&#xD;
         22. Have work hours, family obligations or transportation issues that could interfere with&#xD;
             patient returning for all scheduled evaluations, tests and nutritional counseling.&#xD;
&#xD;
         23. Lives &gt;60 kilometers from investigator site.&#xD;
&#xD;
         24. Patient is not able to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge C. Espinos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centro Medico Teknon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Medico</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>April 1, 2015</last_update_submitted>
  <last_update_submitted_qc>April 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Using POSE as a treatment for Obesity</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/NCT01679158
org study id: TPR600
nct id: NCT01679158
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the impact of minor variations in Incisionless
      Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety,
      and weight loss in the treatment of primary obesity. It will confirm, in an open prospective
      study, the action mechanisms for the "POSE" endoscopic treatment technique for obesity, and
      it will help determine if they are maintained at least 6 months following the procedure.
      Durability of weight loss will be tracked through post-POSE visits up to 18 months following
      the procedure.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Loss
time frame: Monthly post procedure out to 18 months
description: Each patient's weight will be measured and recorded on a monthly basis out to 18 months post procedure
measure: Fasting/Post-prandial Peptides
time frame: pre-procedure & 8 weeks post procedure
description: Samples to be collected when fasting and 30, 60, 90, and 120 minutes after a standard meal (a meal consisting of 400 calories), The meal must be consumed within 10 minutes.. Serum collection tubes will be centrifuged immediately at 4°C for 10 minutes at 3600rpm and stored at -20°C
Samples to be collected by ELISA are: C-peptide, serum insulin, glucose, PYY, GLP-1 (active), leptin, and GIP. Total ghrelin level to be analyzed by RIA.
measure: Gastric Emptying
time frame: Pre-procedure & 2 & 6 months post procedure
description: This test consists of determining the duration of a radioactive marker in a stomach, which is non-absorbable, and free of any food components.
measure: Satiety Testing
time frame: Pre-procedure & 2 & 6 months post procedure
description: The subjects ingest a nutritional drink (Ensure) at a constant rate of 30 mL per minute, constantly filling the glass with a perfusion pump (Gemini PC-2, IMED, San Diego, CA). (The subjects are not conscious of the volume being ingested.) The subjects are instructed to maintain consumption at the fill rate. Participants take note of their sensation of satiety with a graphical classification scale, which combines verbal descriptors on a scale of 0 to 5 (0 = no symptoms, 1 = first sensation of fullness [threshold]; 2 = light, 3 = moderate, 4 = severe, and 5 = maximum fullness or unbearable). The participants are told to stop taking the food product when a score of 5 is obtained. The maximum consumption of volume of the nutritional drink is recorded.
arm group label: Continuous Horizontal row
arm group type: Experimental
description: Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum
arm group label: Reduction in "ring" opening
arm group type: Experimental
description: Use the IOP system from USGI to install suture anchors to reduce the "ring" opening to the antrum
arm group label: Control Arm
arm group type: Experimental
description: Use the IOP system from USGI to install suture anchors in the Current V shape in distal body
intervention type: Device
intervention name: Using The IOP system from USGI to place suture anchors
description: Sutures are placed in the distal body in one of three randomized techniques:
"A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control
arm group label: Continuous Horizontal row
arm group label: Control Arm
arm group label: Reduction in "ring" opening
other name: The g-Cath EZ Suture Anchor Delivery Catheter
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jorge C. Espinos, MD
role: Principal Investigator
affiliation: Centro Medico Teknon
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Obesity