<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/NCT01662024</url>
  </required_header>
  <id_info>
    <org_study_id>2012P-000799</org_study_id>
    <nct_id>NCT01662024</nct_id>
  </id_info>
  <brief_title>Endoscopic Suturing for Primary Obesity Treatment</brief_title>
  <acronym>PROMISE</acronym>
  <official_title>Primary Obesity Multicenter Incisionless Suturing Evaluation: The PROMISE Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Apollo Endosurgery, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastric restriction is an important principle of both roux-en-Y gastric bypass and&#xD;
      laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing&#xD;
      System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric&#xD;
      size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of&#xD;
      this system has the potential to reduce the complications associated with current surgical&#xD;
      approaches while effecting the desired gastric restriction. The primary objective is to&#xD;
      collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery,&#xD;
      Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive&#xD;
      procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing&#xD;
      System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during&#xD;
      primary gastric restrictive procedures.&#xD;
&#xD;
      The primary endpoint of this study is evaluation of safety and feasibility of the procedure.&#xD;
      All subjects for whom the plication procedure is initiated (defined as placement of the&#xD;
      overtube) will be included in the safety analysis. The primary safety analysis will assess&#xD;
      the occurrence of adverse events through 12 months after the plication procedure.&#xD;
&#xD;
      Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic&#xD;
      intervention. Safety will be determined as no adverse events directly related to the&#xD;
      procedure at 12 months.&#xD;
&#xD;
      Secondary Endpoints:&#xD;
&#xD;
        1. Efficacy: Data for the following effectiveness outcome measures (variables) will be&#xD;
           collected and analyzed relative to baseline:&#xD;
&#xD;
             -  Percent excess weight loss (%EWL)&#xD;
&#xD;
             -  Total weight lost (kg) and percent weight lost&#xD;
&#xD;
             -  Change in (BMI) and percent change in BMI&#xD;
&#xD;
             -  Change in waist circumference&#xD;
&#xD;
             -  Improvement in co-morbid disease(s) including, but not limited to, improvement in&#xD;
                vital signs and/or laboratory values&#xD;
&#xD;
             -  Changes in quality of life measures as reported on Quality of Life questionnaire(s)&#xD;
                (evaluated relative to baseline)&#xD;
&#xD;
             -  Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to&#xD;
                baseline)&#xD;
&#xD;
        2. Durability: Data will be collected on the durability of the plications by evaluating the&#xD;
           remaining plications at the 12 month endoscopy, compared to the number of plications&#xD;
           placed at the time of procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">May 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>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of Technical Feasibility of the Procedure</measure>
    <time_frame>Day 0 - Procedure Day</time_frame>
    <description>Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Excess Weight Loss</measure>
    <time_frame>12 Months</time_frame>
    <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Durability</measure>
    <time_frame>12 months</time_frame>
    <description>Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Total Body Weight Loss</measure>
    <time_frame>12 Months</time_frame>
    <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI Loss (kg/m^2)</measure>
    <time_frame>12 Months</time_frame>
    <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist Circumference Loss (cm)</measure>
    <time_frame>12 Months</time_frame>
    <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obesity</condition>
  <condition>Body Weight</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Endoscopic gastric restrictive procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopic gastric restrictive procedure</intervention_name>
    <description>Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures</description>
    <arm_group_label>Endoscopic gastric restrictive procedure</arm_group_label>
    <other_name>Apollo Overstitch Endoscopic Suturing System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has met diabetic lab testing and all pre-procedural qualifications&#xD;
&#xD;
          -  Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age&#xD;
&#xD;
          -  Subject has a BMI of &gt; 30 and &lt; 35&#xD;
&#xD;
          -  Subject has history of obesity for &gt; 2 yrs&#xD;
&#xD;
          -  Subject has had no significant weight change (&lt;5% of total body weight)in last 6&#xD;
             months&#xD;
&#xD;
          -  Subject must have failed standard obesity therapy of diet, exercise, behavior&#xD;
             modification, and pharmacologic agents either alone or in combination, as assessed by&#xD;
             an interview with a member of the study team at baseline&#xD;
&#xD;
          -  Subject is a reasonable candidate for general anesthesia&#xD;
&#xD;
          -  Subject agrees not to have any additional weight loss surgery or reconstructive&#xD;
             surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc)&#xD;
             during the trial&#xD;
&#xD;
          -  Subject must be willing and able to participate in all aspects of the study and agree&#xD;
             to comply with all study requirements for the duration of the study. This includes&#xD;
             availability of reliable transportation and sufficient time to attend all follow-up&#xD;
             visits.&#xD;
&#xD;
          -  Subject must be able to fully understand and be willing to sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has had significant weight loss in the last 3 months, or between baseline and&#xD;
             the study procedure&#xD;
&#xD;
          -  Mallampati (intubation) score greater than 3&#xD;
&#xD;
          -  Subject is observed during EGD to have heavily scarred, malignant or poor&#xD;
             quality/friable tissue in areas of the stomach where sutures are to be placed&#xD;
&#xD;
          -  Subject has history or present use of insulin or insulin derivatives for treatment of&#xD;
             diabetes&#xD;
&#xD;
          -  Subject has diabetes secondary to a specific disease&#xD;
&#xD;
          -  Subject has poorly controlled diabetes as indicated by the lack of stable diabetes&#xD;
             medications and doses over the last month, or has a history of diabetes for greater&#xD;
             than 10 years&#xD;
&#xD;
          -  Subject has history of inflammatory disease of GI tract&#xD;
&#xD;
          -  Subject has a history of intestinal strictures or adhesions&#xD;
&#xD;
          -  Subject has renal and/or hepatic insufficiency&#xD;
&#xD;
          -  Subject has chronic pancreatic disease&#xD;
&#xD;
          -  Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease&#xD;
             and/or active peptic ulcer&#xD;
&#xD;
          -  Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4&#xD;
             reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal&#xD;
             diverticulum, dysphagia, achalasia, or symptoms of dysmotility&#xD;
&#xD;
          -  Subject has a history of any significant abdominal surgery&#xD;
&#xD;
          -  Subject has had previous bariatric, gastric or esophageal surgery; intestinal&#xD;
             obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric&#xD;
             varices, or gastroparesis&#xD;
&#xD;
          -  Subject has a hiatal hernia &gt; 2cm&#xD;
&#xD;
          -  Subject has chronic/acute upper GI bleeding conditions&#xD;
&#xD;
          -  Subject has severe coagulopathy (prothrombin time &gt; 3 seconds over control or platelet&#xD;
             count &lt; 100,000) or is presently taking heparin, coumadin, warfarin, or other&#xD;
             anticoagulants or other medications which impede coagulation or platelet aggregation&#xD;
&#xD;
          -  Female subject is of childbearing age and not practicing effective birth control, is&#xD;
             pregnant or is lactating&#xD;
&#xD;
          -  Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable&#xD;
             coronary artery disease.&#xD;
&#xD;
          -  Subject has cancer or life expectancy of &lt; 2 yrs&#xD;
&#xD;
          -  Subject has systemic infection in the body at the time of the plication procedure.&#xD;
&#xD;
          -  Subject currently uses or has used over the counter or prescription weight loss&#xD;
             medications in last 30 days or intends to use during follow-up Study period.&#xD;
&#xD;
          -  Subjects who have started medications within the last 3 months that are known to cause&#xD;
             weight gain&#xD;
&#xD;
          -  Subjects undergoing chronic steroid therapy&#xD;
&#xD;
          -  Subjects undergoing immunosuppressive therapy&#xD;
&#xD;
          -  Subject has a history of drug or alcohol abuse&#xD;
&#xD;
          -  Subject has a history of uncontrolled or poorly controlled psychiatric disease or&#xD;
             suspected eating disorders&#xD;
&#xD;
          -  Subject is non-ambulatory or has significant impairment of mobility&#xD;
&#xD;
          -  Subject has known hormonal or genetic cause for obesity&#xD;
&#xD;
          -  Subject is not in sufficient and stable medical health, as determined and evaluated by&#xD;
             the Principal Investigator.&#xD;
&#xD;
          -  Subject has participated in a clinical study with an investigational new drug,&#xD;
             biological, or therapeutic device within ≤ 28 days prior to enrollment in this study,&#xD;
             and does not agree to abstain from participation in other clinical trials of any kind&#xD;
             during this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher C. Thompson, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jackson Health System</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Regional Medical Center at New Jersey</name>
      <address>
        <city>Paterson</city>
        <state>New Jersey</state>
        <zip>07503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas at Houston</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.</citation>
    <PMID>16595758</PMID>
  </reference>
  <reference>
    <citation>Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.</citation>
    <PMID>10432328</PMID>
  </reference>
  <reference>
    <citation>Dindo D, Muller MK, Weber M, Clavien PA. Obesity in general elective surgery. Lancet. 2003 Jun 14;361(9374):2032-5. doi: 10.1016/S0140-6736(03)13640-9.</citation>
    <PMID>12814714</PMID>
  </reference>
  <reference>
    <citation>Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.</citation>
    <PMID>15616203</PMID>
  </reference>
  <reference>
    <citation>Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based analysis. J Am Coll Surg. 2004 Oct;199(4):543-51. doi: 10.1016/j.jamcollsurg.2004.06.014.</citation>
    <PMID>15454136</PMID>
  </reference>
  <reference>
    <citation>Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc. 2002 Feb;16(2):230-3. doi: 10.1007/s004640080187. Epub 2001 Oct 5.</citation>
    <PMID>11967669</PMID>
  </reference>
  <reference>
    <citation>Jirapinyo P, Watson RR, Thompson CC. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc. 2012 Aug;76(2):435-9. doi: 10.1016/j.gie.2012.03.681. Epub 2012 May 31. No abstract available.</citation>
    <PMID>22658388</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>June 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>December 7, 2016</results_first_submitted>
  <results_first_submitted_qc>February 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2017</results_first_posted>
  <last_update_submitted>February 12, 2017</last_update_submitted>
  <last_update_submitted_qc>February 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Christopher Thompson</investigator_full_name>
    <investigator_title>Director of Therapeutic Endoscopy</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>BMI</keyword>
  <keyword>Weight loss</keyword>
  <keyword>Gastric restriction</keyword>
  <keyword>Bariatrics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data is available immediately. We will share the outcomes data if a request is made via email to the PI and the data transfer is completed between institutions. Identifying information will not be provided.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Endoscopic Gastric Restrictive Procedure</title>
          <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Adults who are suffering from obesity with a Body Mass Index (BMI) of 30 - 35 kg/m^2 seeking a minimally invasive alternative to bariatric surgery.</population>
      <group_list>
        <group group_id="B1">
          <title>Endoscopic Gastric Restrictive Procedure</title>
          <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.7" lower_limit="34.4" upper_limit="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Initial Weight (kg)</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90.4" lower_limit="88.4" upper_limit="92.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Initial BMI (kg/m^2)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.4" lower_limit="33.1" upper_limit="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Gastric Restrictive Procedure</title>
            <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Peri-operative Adverse Events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-operative Adverse Events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Delayed Adverse Events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Adverse Events</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of Technical Feasibility of the Procedure</title>
        <description>Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.</description>
        <time_frame>Day 0 - Procedure Day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Gastric Restrictive Procedure</title>
            <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. D</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Technical Feasibility of the Procedure</title>
          <description>Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.</description>
          <units>Sutures</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Running Sutures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="9.9" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Stitches</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4" lower_limit="51.9" upper_limit="56.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interrupted Sutures</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="4" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Excess Weight Loss</title>
        <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Gastric Restrictive Procedure</title>
            <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Excess Weight Loss</title>
          <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss</description>
          <units>Percentage of excess weight lost</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8" lower_limit="62.8" upper_limit="78.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Durability</title>
        <description>Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.</description>
        <time_frame>12 months</time_frame>
        <population>Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.</population>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Gastric Restrictive Procedure</title>
            <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures</description>
          </group>
        </group_list>
        <measure>
          <title>Durability</title>
          <description>Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.</description>
          <population>Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Total Body Weight Loss</title>
        <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Gastric Restrictive Procedure</title>
            <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Total Body Weight Loss</title>
          <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss</description>
          <units>Percentage of total weight lost</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" lower_limit="15.8" upper_limit="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMI Loss (kg/m^2)</title>
        <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Gastric Restrictive Procedure</title>
            <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>BMI Loss (kg/m^2)</title>
          <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="5.3" upper_limit="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Waist Circumference Loss (cm)</title>
        <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Gastric Restrictive Procedure</title>
            <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.</description>
          </group>
        </group_list>
        <measure>
          <title>Waist Circumference Loss (cm)</title>
          <description>Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)</description>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="13.6" upper_limit="18.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 month period of adverse event data collection.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Endoscopic Gastric Restrictive Procedure</title>
          <description>Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.&#xD;
Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Perioperative Abdominal Pain</sub_title>
                <description>Perioperative Adverse Event is on Day of procedure (Day 0)</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Perioperative Nausea/Vomiting</sub_title>
                <description>Perioperative Adverse Event is on Day of procedure (Day 0)</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Post-operative Abdominal Pain</sub_title>
                <description>Post-operative reporting is 1-3 days after the procedure</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Post-operative Nausea</sub_title>
                <description>Post-operative reporting is 1-3 days after the procedure</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination and withdrawal of 5 subjects leads to small numbers of subjects analyzed.&#xD;
No sham comparator.&#xD;
Durability measures at 12 month endoscopy was difficult to quantify.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Christopher C. Thompson, MD, MSc</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>617-525-8266</phone>
      <email>ccthompson@bwh.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01662024
org study id: 2012P-000799
nct id: NCT01662024
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Gastric restriction is an important principle of both roux-en-Y gastric bypass and
      laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing
      System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric
      size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of
      this system has the potential to reduce the complications associated with current surgical
      approaches while effecting the desired gastric restriction. The primary objective is to
      collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery,
      Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive
      procedures.
The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing
      System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during
      primary gastric restrictive procedures.

      The primary endpoint of this study is evaluation of safety and feasibility of the procedure.
      All subjects for whom the plication procedure is initiated (defined as placement of the
      overtube) will be included in the safety analysis. The primary safety analysis will assess
      the occurrence of adverse events through 12 months after the plication procedure.

      Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic
      intervention. Safety will be determined as no adverse events directly related to the
      procedure at 12 months.

      Secondary Endpoints:

        1. Efficacy: Data for the following effectiveness outcome measures (variables) will be
           collected and analyzed relative to baseline:

             -  Percent excess weight loss (%EWL)

             -  Total weight lost (kg) and percent weight lost

             -  Change in (BMI) and percent change in BMI

             -  Change in waist circumference

             -  Improvement in co-morbid disease(s) including, but not limited to, improvement in
                vital signs and/or laboratory values

             -  Changes in quality of life measures as reported on Quality of Life questionnaire(s)
                (evaluated relative to baseline)

             -  Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to
                baseline)

        2. Durability: Data will be collected on the durability of the plications by evaluating the
           remaining plications at the 12 month endoscopy, compared to the number of plications
           placed at the time of procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open label
measure: Number of Participants With Adverse Events
time frame: 12 months
description: Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.
measure: Evaluation of Technical Feasibility of the Procedure
time frame: Day 0 - Procedure Day
description: Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.
measure: Percent Excess Weight Loss
time frame: 12 Months
description: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss
measure: Durability
time frame: 12 months
description: Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.
measure: Percentage of Total Body Weight Loss
time frame: 12 Months
description: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss
measure: BMI Loss (kg/m^2)
time frame: 12 Months
description: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)
measure: Waist Circumference Loss (cm)
time frame: 12 Months
description: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)
arm group label: Endoscopic gastric restrictive procedure
arm group type: Experimental
description: Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.
intervention type: Device
intervention name: Endoscopic gastric restrictive procedure
description: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
arm group label: Endoscopic gastric restrictive procedure
other name: Apollo Overstitch Endoscopic Suturing System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Christopher C. Thompson, MD, MS
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PMID: 16595758
citation: Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.
PMID: 10432328
citation: Dindo D, Muller MK, Weber M, Clavien PA. Obesity in general elective surgery. Lancet. 2003 Jun 14;361(9374):2032-5. doi: 10.1016/S0140-6736(03)13640-9.
PMID: 12814714
citation: Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
PMID: 15616203
citation: Flum DR, Dellinger EP. Impact of gastric bypass operation on survival: a population-based analysis. J Am Coll Surg. 2004 Oct;199(4):543-51. doi: 10.1016/j.jamcollsurg.2004.06.014.
PMID: 15454136
citation: Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc. 2002 Feb;16(2):230-3. doi: 10.1007/s004640080187. Epub 2001 Oct 5.
PMID: 11967669
citation: Jirapinyo P, Watson RR, Thompson CC. Use of a novel endoscopic suturing device to treat recalcitrant marginal ulceration (with video). Gastrointest Endosc. 2012 Aug;76(2):435-9. doi: 10.1016/j.gie.2012.03.681. Epub 2012 May 31. No abstract available.
PMID: 22658388
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Christopher Thompson
investigator title: Director of Therapeutic Endoscopy
mesh term: Obesity
mesh term: Overweight
mesh term: Body Weight
sharing ipd: Yes
ipd description: Data is available immediately. We will share the outcomes data if a request is made via email to the PI and the data transfer is completed between institutions. Identifying information will not be provided.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination and withdrawal of 5 subjects leads to small numbers of subjects analyzed.
No sham comparator.
Durability measures at 12 month endoscopy was difficult to quantify.
point of contact: 