<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/NCT01682733</url>
  </required_header>
  <id_info>
    <org_study_id>12-003195</org_study_id>
    <nct_id>NCT01682733</nct_id>
  </id_info>
  <brief_title>Endoscopic Gastric Reduction for Weight Management</brief_title>
  <official_title>Endoscopic Gastric Reduction for Weight Management: A Pilot Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is a prospective, pilot study to assess the feasibility of a novel&#xD;
      endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for&#xD;
      the primary treatment of obesity. The investigators aim to recruit ten subjects with a body&#xD;
      mass index between 30-40 for this study. Vertical sutures will be performed using the&#xD;
      endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum&#xD;
      toxin(approximately 30 units) will be injected around the sutures insertion sites in half of&#xD;
      the subjects randomly to slow down muscular grinding of the stomach to see if it improves&#xD;
      durability of the procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</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 from baseline Bariatric Quality of Life (BQL) Questionaire</measure>
    <time_frame>baseline to 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Three factor Eating Questionnaire (TFEQ-R21)</measure>
    <time_frame>baseline to 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin at injection site</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin</intervention_name>
    <description>In this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty.</description>
    <arm_group_label>Botulinum toxin at injection site</arm_group_label>
    <other_name>Botox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Overstitch Endoscopic Suturing System</intervention_name>
    <description>The gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System.</description>
    <arm_group_label>Botulinum toxin at injection site</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) between 30 and 40&#xD;
&#xD;
          -  Age &gt;18 and ≤50&#xD;
&#xD;
          -  Stable weight for 3 months (within 5% of BMI)&#xD;
&#xD;
          -  Normal basic labs (CBC, chemistry profile, creatinine)&#xD;
&#xD;
          -  Negative pregnancy test for females &gt;18 or ≤ 50&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Unstable coronary artery disease&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
          -  Cardiac arrhythmia&#xD;
&#xD;
          -  Cardiac valvular disease&#xD;
&#xD;
          -  Obstructive of interstitial lung disease&#xD;
&#xD;
          -  Females of child-bearing age &gt;18 or ≤ 50 who are pregnant or lactating&#xD;
&#xD;
          -  Mallampati score of 4&#xD;
&#xD;
          -  ASA 3 or above&#xD;
&#xD;
          -  Previous gastric surgery&#xD;
&#xD;
          -  Ulcer disease&#xD;
&#xD;
          -  Gastroparesis,&#xD;
&#xD;
          -  &gt; 5 cm Hiatal hernia&#xD;
&#xD;
          -  Congenital anomalies of the GI tract&#xD;
&#xD;
          -  Currently on or prescribed a medication known to affect weight within 3 months of&#xD;
             study entry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barham K AbuDayyeh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Foundation</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>April 6, 2015</last_update_submitted>
  <last_update_submitted_qc>April 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Barham K. Abu Dayyeh, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Weight loss</keyword>
  <keyword>Gastric reduction (volume)</keyword>
  <keyword>BMI 30-40</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
  </intervention_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/NCT01682733
org study id: 12-003195
nct id: NCT01682733
lead sponsor: 
has dmc: Yes
The proposed study is a prospective, pilot study to assess the feasibility of a novel
      endoscopic suturing system to reduce gastric volume by changing the shape of the stomach for
      the primary treatment of obesity. The investigators aim to recruit ten subjects with a body
      mass index between 30-40 for this study. Vertical sutures will be performed using the
      endoscopic suturing system to deploy 10-17 interrupted full thickness sutures. Botulinum
      toxin(approximately 30 units) will be injected around the sutures insertion sites in half of
      the subjects randomly to slow down muscular grinding of the stomach to see if it improves
      durability of the procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline Bariatric Quality of Life (BQL) Questionaire
time frame: baseline to 3 months
measure: Change from baseline Three factor Eating Questionnaire (TFEQ-R21)
time frame: baseline to 3 months
arm group label: Botulinum toxin at injection site
arm group type: Experimental
description: All subjects will have gastroplasty performed using the Overstitch Endoscopic Suturing System. Botulinum toxin will be injected in every other suture site in half of the randomly patients selected.
intervention type: Drug
intervention name: Botulinum toxin
description: In this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty.
arm group label: Botulinum toxin at injection site
other name: Botox
intervention type: Device
intervention name: Overstitch Endoscopic Suturing System
description: The gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System.
arm group label: Botulinum toxin at injection site
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Barham K AbuDayyeh, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Barham K. Abu Dayyeh, M.D.
investigator title: Principal Investigator
mesh term: Obesity
mesh term: Botulinum Toxins