<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/NCT02191501</url>
  </required_header>
  <id_info>
    <org_study_id>Feinstein IRB#13-037B</org_study_id>
    <nct_id>NCT02191501</nct_id>
  </id_info>
  <brief_title>Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity</brief_title>
  <official_title>Endoscopic Suturing of the Gastric Pylorus to Delay Gastric Emptying and Treat Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Society for Gastrointestinal Endoscopy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of&#xD;
      the gastric pylorus to delay gastric emptying and treat obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the safety, technical feasibility, and effectiveness&#xD;
      of a endoscopic guided treatment for obesity - endoscopic pyloric suturing. The hypothesis&#xD;
      and rationale for the study is that gastric pyloric restriction will cause early and&#xD;
      prolonged satiety which will lead to decreased food intake and eventual weight loss. Both&#xD;
      safety and efficacy of endoscopic pyloric suturing has been demonstrated in an animal model.&#xD;
&#xD;
      Screening of the participant is done 6-8 weeks prior to the procedure. Screening includes&#xD;
      general history and physical examination, biochemical and laboratory analysis and informed&#xD;
      consent. A baseline patient visit is performed 4-6 weeks prior to the procedure. The baseline&#xD;
      visit involves a four hour gastric emptying scan in order to determine the rate of emptying&#xD;
      of the stomach, the regional emptying of the upper and lower stomach, and the frequency and&#xD;
      amplitude of contractions in the lower stomach. The baseline visit also includes nutritional&#xD;
      counselling.&#xD;
&#xD;
      The procedure is performed in the endoscopy suite as an outpatient procedure. Patient will be&#xD;
      prepped following usual practices and placed in a left lateral decubitus position. Following&#xD;
      induction of sedation or anesthesia by the anesthesia provider, a complete endoscopic&#xD;
      evaluation of the esophagus, stomach and jejunum following standard medical practices will be&#xD;
      performed. The endoscope with mounted suturing device is advanced through an over-tube to the&#xD;
      antrum and assess target area for stitch placement (physician will select appropriate target&#xD;
      site in relation to participant's anatomy). The number of sutures required will vary for each&#xD;
      procedure based on the size of the pylorus; however, it is thought that one or two sutures&#xD;
      across the pylorus will be sufficient enough to achieve a functional restriction of the&#xD;
      pylorus.&#xD;
&#xD;
      Participants will to be observed for a minimum of 1 hour following the procedure to monitor&#xD;
      for adverse events. Patients will be recommended to take the following medications in order&#xD;
      to minimize complications following pyloric suturing procedure; Proton Pump Inhibitor&#xD;
      Omeprazole 40 mg recommended daily for 1 week prior to planned procedure date - and 40 mg&#xD;
      twice daily after the procedure, Anti-Emetic -- Reglan or Zofran at the end of procedure and&#xD;
      as needed after the procedure, and Scopalamine Patch to prevent nausea and vomiting.&#xD;
&#xD;
      All participants will be required to adhere to the follow-up schedule outlined below unless&#xD;
      they have withdrawn their consent or died. The reason(s) the participant is not followed will&#xD;
      be documented by the investigator. Follow-up for all participants will include a telephone&#xD;
      contact at 1 and 18 weeks and clinic visits at 2,4, 8,10,12 and 24 weeks. At the 4 week&#xD;
      visit, the participants will undergo a repeat four hour gastric emptying scan. At 3 months&#xD;
      after the procedure participants will undergo repeat endoscopy to access the stomach and the&#xD;
      suture site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Suspended as we are looking for more durable method/device&#xD;
  </why_stopped>
  <start_date type="Actual">May 7, 2013</start_date>
  <completion_date type="Actual">November 9, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</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>Percent weight loss</measure>
    <time_frame>At 1, 3 and 6 months</time_frame>
    <description>The primary endpoint of this study is percent weight loss at 1, 3 and 6 months (using the weight taken at the baseline visit as the baseline weight). Percent weight lost will be calculated as follows: [(Baseline Weight - Final 6 month Weight)/Baseline Weight] x 100%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction</measure>
    <time_frame>At 6 months post procedure</time_frame>
    <description>Participant satisfaction with clinical outcomes at 6 months post-procedure will be captured on an ordinal scale of 1 to 5 with 1 representing very satisfied and 5 representing not satisfied at all. The response will be tabulated and presented using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay in gastric emptying</measure>
    <time_frame>From baseline to 4 weeks post procedure</time_frame>
    <description>A gastric emptying scan will be done prior to the endoscopic suturing procedure and four weeks after the endoscopic procedure to determine the rate of emptying of the stomach, the regional emptying of the upper and lower stomach, and the frequency and amplitude of contractions in the lower stomach.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BMI</measure>
    <time_frame>At 1, 3 and 6 Months</time_frame>
    <description>BMI at 1, 3 and 6 months will be tabulated and summarized using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders</measure>
    <time_frame>At 1, 3 and 6 Months</time_frame>
    <description>Percentage of participants losing at least 5%, 10%, 15% and 20% of weight at 1, 3 and 6 months will be tabulated and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Use.</measure>
    <time_frame>At 1, 3 and 6 Months</time_frame>
    <description>If the participant is taking any medications for Obesity related complications such as Hypertension and Diabetes, then the dosage of those medications at 1, 3 and 6 months will be recorded and trends will be noted as either remained the same, decreased or increased.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Obesity</condition>
  <condition>Over Weight</condition>
  <arm_group>
    <arm_group_label>Pyloric restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endoscopic method of pyloric restriction in order to decrease gastric emptying. The hypothesis is that this will cause and early and prolonged satiety which will inturn lead to decreased food consumption and lead to weight loss.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pyloric restriction</intervention_name>
    <description>The Apollo Overstitch Suturing Device is FDA approved for suturing in the gastrointestinal tract.&#xD;
However, the suturing device has never been used for suturing the pylorus in humans before. This procedure is not standard medical care. The safety and effectiveness of this procedure are being tested.</description>
    <arm_group_label>Pyloric restriction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18- 65&#xD;
&#xD;
          -  Male or female participants with a BMI &gt;30 and &lt; 45&#xD;
&#xD;
          -  Female participants of childbearing age should not be pregnant, must have a negative&#xD;
             serum or urine test and agree to use birth control for duration of the study.&#xD;
&#xD;
          -  Participant did not undergo previous Roux-en-Y bypass with the gastric pouch limited&#xD;
             to the cardia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to eggs or egg products, wheat, Gluten or Prolamins.&#xD;
&#xD;
          -  currently on life saving oral medications&#xD;
&#xD;
          -  Participants allergic to Scopolamine&#xD;
&#xD;
          -  Participants allergic to botulinum toxin&#xD;
&#xD;
          -  Participants who are currently on oral medications for their serious medical&#xD;
             conditions.&#xD;
&#xD;
          -  Recent tobacco cessation (within 3 months prior to planned enrollment) or plan to quit&#xD;
             smoking during the study&#xD;
&#xD;
          -  Infection anywhere in the body at time of procedure or other diseases that would make&#xD;
             participant unsuitable for treatment (e.g., systemic disease, HIV, malignancy,&#xD;
             autoimmune disease, etc.)&#xD;
&#xD;
          -  patients who cannot undergo endoscopy&#xD;
&#xD;
          -  Active disease of the gastrointestinal tract including esophageal inflammation,&#xD;
             varices or ulceration, or specific inflammation such as Crohn's disease or ulcerative&#xD;
             colitis&#xD;
&#xD;
          -  Esophageal or cricopharyngeal narrowing or stricture; distorted esophagus or known&#xD;
             esophageal pouch&#xD;
&#xD;
          -  Heavily scarred, malignant, or poor quality (e.g., friable or overly compliant) tissue&#xD;
             in area to be sutured&#xD;
&#xD;
          -  Severe eating disorders such as bulimia (use of purgatives/laxatives) or anorexia&#xD;
             nervosa&#xD;
&#xD;
          -  Significant movement limitations of lower extremities (e.g., cannot walk without the&#xD;
             use of, or assistance from, a brace, cane, crutch, another person, prosthetic device,&#xD;
             wheelchair, or other assistive device or is severely limited in their ability to walk&#xD;
             due to an arthritic, neurological, or orthopedic condition)&#xD;
&#xD;
          -  Recently (within previous 3 months) prescribed or initiated therapy with medication(s)&#xD;
             known to cause significant weight gain or likely to require treatment with such&#xD;
             medication(s) during the study OR is currently taking or has taken within the previous&#xD;
             3 months prescription or over-the-counter weight loss medications (e.g., medications&#xD;
             and/or supplements containing ephedrine, phenylpropanolamine, amphetamines, etc.).&#xD;
             Additionally, use of such medications and weight loss/appetite suppressing dietary&#xD;
             supplements are prohibited during the course of the trial including the screening&#xD;
             period&#xD;
&#xD;
          -  Participant has history of significant cardiovascular or pulmonary disease (e.g.,&#xD;
             myocardial infarct, unstable angina, congestive heart failure, pulmonary edema or&#xD;
             COPD) or other significant cerebrovascular disease (e.g., stroke)&#xD;
&#xD;
          -  Not a candidate for general or conscious/moderate sedation&#xD;
&#xD;
          -  Participant is on anticoagulant therapy (heparin, coumadin, Plavix, Ticlid, etc.) and&#xD;
             must discontinue use of 325 mg aspirin within 6 weeks of procedure&#xD;
&#xD;
          -  Active substance abuse (e.g., alcohol or drugs). This is done with personal interview&#xD;
             only. No drug tests are being performed to determine the active abuse&#xD;
&#xD;
          -  The participant has life expectancy of less than 1 year due to other medical&#xD;
             conditions&#xD;
&#xD;
          -  The participant is currently enrolled in another investigational drug or device trial&#xD;
             that has not completed the primary endpoint or that clinically interferes with this&#xD;
             trials study endpoints&#xD;
&#xD;
          -  Patients having Diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larry S Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Feinstein Institute for Medical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.feinsteininstitute.org/clinical-research/clinical-research-studies/clinical-trial/13-037B/</url>
    <description>Description and location of study</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Larry Miller</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Obesity Treatment</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Pyloric Suturing</keyword>
  <keyword>Pyloric restriction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02191501
org study id: Feinstein IRB#13-037B
nct id: NCT02191501
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to demonstrate the efficacy and safety of endoscopic suturing of
      the gastric pylorus to delay gastric emptying and treat obesity.
The purpose of this study is to evaluate the safety, technical feasibility, and effectiveness
      of a endoscopic guided treatment for obesity - endoscopic pyloric suturing. The hypothesis
      and rationale for the study is that gastric pyloric restriction will cause early and
      prolonged satiety which will lead to decreased food intake and eventual weight loss. Both
      safety and efficacy of endoscopic pyloric suturing has been demonstrated in an animal model.

      Screening of the participant is done 6-8 weeks prior to the procedure. Screening includes
      general history and physical examination, biochemical and laboratory analysis and informed
      consent. A baseline patient visit is performed 4-6 weeks prior to the procedure. The baseline
      visit involves a four hour gastric emptying scan in order to determine the rate of emptying
      of the stomach, the regional emptying of the upper and lower stomach, and the frequency and
      amplitude of contractions in the lower stomach. The baseline visit also includes nutritional
      counselling.

      The procedure is performed in the endoscopy suite as an outpatient procedure. Patient will be
      prepped following usual practices and placed in a left lateral decubitus position. Following
      induction of sedation or anesthesia by the anesthesia provider, a complete endoscopic
      evaluation of the esophagus, stomach and jejunum following standard medical practices will be
      performed. The endoscope with mounted suturing device is advanced through an over-tube to the
      antrum and assess target area for stitch placement (physician will select appropriate target
      site in relation to participant's anatomy). The number of sutures required will vary for each
      procedure based on the size of the pylorus; however, it is thought that one or two sutures
      across the pylorus will be sufficient enough to achieve a functional restriction of the
      pylorus.

      Participants will to be observed for a minimum of 1 hour following the procedure to monitor
      for adverse events. Patients will be recommended to take the following medications in order
      to minimize complications following pyloric suturing procedure; Proton Pump Inhibitor
      Omeprazole 40 mg recommended daily for 1 week prior to planned procedure date - and 40 mg
      twice daily after the procedure, Anti-Emetic -- Reglan or Zofran at the end of procedure and
      as needed after the procedure, and Scopalamine Patch to prevent nausea and vomiting.

      All participants will be required to adhere to the follow-up schedule outlined below unless
      they have withdrawn their consent or died. The reason(s) the participant is not followed will
      be documented by the investigator. Follow-up for all participants will include a telephone
      contact at 1 and 18 weeks and clinic visits at 2,4, 8,10,12 and 24 weeks. At the 4 week
      visit, the participants will undergo a repeat four hour gastric emptying scan. At 3 months
      after the procedure participants will undergo repeat endoscopy to access the stomach and the
      suture site.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent weight loss
time frame: At 1, 3 and 6 months
description: The primary endpoint of this study is percent weight loss at 1, 3 and 6 months (using the weight taken at the baseline visit as the baseline weight). Percent weight lost will be calculated as follows: [(Baseline Weight - Final 6 month Weight)/Baseline Weight] x 100%.
measure: Participant satisfaction
time frame: At 6 months post procedure
description: Participant satisfaction with clinical outcomes at 6 months post-procedure will be captured on an ordinal scale of 1 to 5 with 1 representing very satisfied and 5 representing not satisfied at all. The response will be tabulated and presented using descriptive statistics.
measure: Delay in gastric emptying
time frame: From baseline to 4 weeks post procedure
description: A gastric emptying scan will be done prior to the endoscopic suturing procedure and four weeks after the endoscopic procedure to determine the rate of emptying of the stomach, the regional emptying of the upper and lower stomach, and the frequency and amplitude of contractions in the lower stomach.
measure: Change in BMI
time frame: At 1, 3 and 6 Months
description: BMI at 1, 3 and 6 months will be tabulated and summarized using descriptive statistics.
measure: Percentage of Responders
time frame: At 1, 3 and 6 Months
description: Percentage of participants losing at least 5%, 10%, 15% and 20% of weight at 1, 3 and 6 months will be tabulated and reported.
measure: Change in Medication Use.
time frame: At 1, 3 and 6 Months
description: If the participant is taking any medications for Obesity related complications such as Hypertension and Diabetes, then the dosage of those medications at 1, 3 and 6 months will be recorded and trends will be noted as either remained the same, decreased or increased.
arm group label: Pyloric restriction
arm group type: Experimental
description: Endoscopic method of pyloric restriction in order to decrease gastric emptying. The hypothesis is that this will cause and early and prolonged satiety which will inturn lead to decreased food consumption and lead to weight loss.
intervention type: Procedure
intervention name: Pyloric restriction
description: The Apollo Overstitch Suturing Device is FDA approved for suturing in the gastrointestinal tract.
However, the suturing device has never been used for suturing the pylorus in humans before. This procedure is not standard medical care. The safety and effectiveness of this procedure are being tested.
arm group label: Pyloric restriction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Larry S Miller, MD
role: Principal Investigator
affiliation: The Feinstein Institute for Medical Research
facility: 
country: United States
url: http://www.feinsteininstitute.org/clinical-research/clinical-research-studies/clinical-trial/13-037B/
description: Description and location of study
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Larry Miller
investigator title: PI
mesh term: Obesity
mesh term: Overweight
sharing ipd: No