<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/NCT01703546</url>
  </required_header>
  <id_info>
    <org_study_id>11-277A</org_study_id>
    <nct_id>NCT01703546</nct_id>
  </id_info>
  <brief_title>Weight Loss &amp; Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication</brief_title>
  <official_title>Weight Loss &amp; CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate whether combining laparoscopic adjustable&#xD;
      gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks&#xD;
      in the large curve of the stomach with stitches) to lap-band surgery alone will result in a&#xD;
      greater loss of excess weight over time. We anticipate that the average percent of excess&#xD;
      body weight loss for study subjects will exceed 29% at 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide&#xD;
      lasting weight loss benefits to patients. We are projecting that the percent of Excess Body&#xD;
      Weight Loss (% EWL) will be greater in study subjects when compared with our control group&#xD;
      with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be&#xD;
      similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 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>
  </study_design_info>
  <primary_outcome>
    <measure>% Excess Body Weight Loss (%EWL)</measure>
    <time_frame>6 months post procedure</time_frame>
    <description>Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HgbA1c</measure>
    <time_frame>12 months post procedure</time_frame>
    <description>A baseline HgbA1c will be obtained pre-operatively for study patients with a comorbid diagnosis of Type 2 Diabetes. HgbA1C will also be obtained at 6 months and 12 months to evaluate the change from the baseline HgbA1C.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">420</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>LAGB &amp; LGCP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All study patients will have the following surgical procedure: Laparoscopic Adjustable Gastric Banding and Gastric Plication (LAGB &amp; LGCP).&#xD;
The percent of Excess Body Weight Loss will be monitored at all post op visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LAGB &amp; LGCP</intervention_name>
    <description>All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band &amp; Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.</description>
    <arm_group_label>LAGB &amp; LGCP</arm_group_label>
    <other_name>Laparoscopic Adjustable Gastric Band &amp; Gastric Plication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 35&#xD;
&#xD;
          -  Meet ASMBS and NIH criteria for Weight Loss Surgery&#xD;
&#xD;
          -  ASA Class I - III&#xD;
&#xD;
          -  Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective&#xD;
             procedure that would affect body weight for the duration of the trial.&#xD;
&#xD;
          -  English speaking &amp; comprehension&#xD;
&#xD;
          -  Normal mental caliber.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, Liver failure or Kidney failure&#xD;
&#xD;
          -  Women of childbearing potential lactating at the time of initial consult or at the&#xD;
             time of surgery&#xD;
&#xD;
          -  Any condition which precludes compliance with the study&#xD;
&#xD;
          -  History or presence of pre-existing autoimmune connective tissue disease or cancer&#xD;
             must be evaluated on a case by case basis by the Director of Bariatric Surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Ward, MD</last_name>
    <role>Study Chair</role>
    <affiliation>North Shore LIJ Health System, Syosset Hospital, Director of Surgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Allison Barrett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Shore LIJ Health System Syosset Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike</name>
      <address>
        <city>Syosset</city>
        <state>New York</state>
        <zip>11791</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Syosset Hospital, Center for Bariatric Surgical Specialties</name>
      <address>
        <city>Syosset</city>
        <state>New York</state>
        <zip>11791</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>January 12, 2016</last_update_submitted>
  <last_update_submitted_qc>January 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Allison Barrett</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Morbid Obesity</keyword>
  <keyword>Weight Loss Surgery</keyword>
  <keyword>Laparoscopic Adjustable Gastric Band</keyword>
  <keyword>Laparoscopic Gastric Plication</keyword>
  <keyword>Imbrication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Weight Loss</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/NCT01703546
org study id: 11-277A
nct id: NCT01703546
lead sponsor: 
has dmc: Yes
The purpose of this research study is to evaluate whether combining laparoscopic adjustable
      gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks
      in the large curve of the stomach with stitches) to lap-band surgery alone will result in a
      greater loss of excess weight over time. We anticipate that the average percent of excess
      body weight loss for study subjects will exceed 29% at 12 months.
Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide
      lasting weight loss benefits to patients. We are projecting that the percent of Excess Body
      Weight Loss (% EWL) will be greater in study subjects when compared with our control group
      with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be
      similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % Excess Body Weight Loss (%EWL)
time frame: 6 months post procedure
description: Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater.
measure: HgbA1c
time frame: 12 months post procedure
description: A baseline HgbA1c will be obtained pre-operatively for study patients with a comorbid diagnosis of Type 2 Diabetes. HgbA1C will also be obtained at 6 months and 12 months to evaluate the change from the baseline HgbA1C.
arm group label: LAGB & LGCP
arm group type: Experimental
description: All study patients will have the following surgical procedure: Laparoscopic Adjustable Gastric Banding and Gastric Plication (LAGB & LGCP).
The percent of Excess Body Weight Loss will be monitored at all post op visits.
intervention type: Procedure
intervention name: LAGB & LGCP
description: All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band & Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.
arm group label: LAGB & LGCP
other name: Laparoscopic Adjustable Gastric Band & Gastric Plication
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Ward, MD
role: Study Chair
affiliation: North Shore LIJ Health System, Syosset Hospital, Director of Surgery
last name: Allison Barrett, MD
role: Principal Investigator
affiliation: North Shore LIJ Health System Syosset Hospital
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Allison Barrett
investigator title: Principal Investigator
mesh term: Obesity, Morbid
mesh term: Weight Loss