<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/NCT03261453</url>
  </required_header>
  <id_info>
    <org_study_id>TRL-1000-0002</org_study_id>
    <nct_id>NCT03261453</nct_id>
  </id_info>
  <brief_title>THE ENLIGHTEN STUDY</brief_title>
  <official_title>A Randomized, Multi-Center, Phased, Pivotal Safety and Efficacy Study Comparing the Elipse™ Gastric Balloon System vs. Sham for the Treatment of Obese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allurion Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allurion Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to demonstrate the safety and efficacy of the Elipse&#xD;
      Gastric Balloon System for the treatment of obese adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, double-blinded, randomized, two-phase study to be conducted in a&#xD;
      planned 400 obese individuals drawn from up to 15 sites. The treatment duration of the study&#xD;
      is 48 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks</measure>
    <time_frame>16 weeks</time_frame>
    <description>An inferential test of whether the Treatment Group Responder Rate (RR) dichotomized at 5% TBWL at 16 weeks is significantly greater than 35%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group</measure>
    <time_frame>16 weeks</time_frame>
    <description>An inferential test of whether the Treatment Group mean %TBWL is significantly greater than Control Group mean % TBWL at 16 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events</measure>
    <time_frame>24 weeks</time_frame>
    <description>The primary safety endpoint of this clinical investigation is the overall incidence of procedure- or device-related Serious Adverse Events through 24 weeks.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to treatment will receive the Elipse device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients randomized to the control arm will receive the sham device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Elipse Device</intervention_name>
    <description>Intervention Device</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Elipse Gastric Balloon System (active)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Elipse Sham Device</intervention_name>
    <description>Control Device</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Elipse Gastric Balloon System (control)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 22 years and ≤ 65 years of age&#xD;
&#xD;
          2. BMI ≥30 kg/m2 and ≤ 40 kg/m2&#xD;
&#xD;
          3. Have signed study specific Informed Consent Form&#xD;
&#xD;
          4. Willing to comply with study requirements, including follow-up visits&#xD;
&#xD;
          5. Documented negative pregnancy test in women of childbearing potential.&#xD;
&#xD;
          6. Women of childbearing potential not intending to become pregnant for the duration of&#xD;
             study participation. (Note: Women of childbearing potential must not be nursing at the&#xD;
             time of treatment).&#xD;
&#xD;
          7. Fully ambulatory without any severe chronic orthopedic disease that requires reliance&#xD;
             on crutches, walkers or a wheelchair that could preclude exercise during the study.&#xD;
&#xD;
          8. Confirmed unsuccessful attempts at more conservative weight reduction alternatives,&#xD;
             such as supervised diet, exercise and behavior modification programs attempted within&#xD;
             the 24 months preceding enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery&#xD;
             disease&#xD;
&#xD;
          2. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD),&#xD;
             pneumonia or cancer&#xD;
&#xD;
          3. Previous bariatric or gastric surgery or likely to undergo during study&#xD;
&#xD;
          4. Use of an intragastric device prior to this study&#xD;
&#xD;
          5. Chronic pancreatitis or acute pancreatitis within 12 months of enrollment&#xD;
&#xD;
          6. History of or current small bowel obstructions&#xD;
&#xD;
          7. History of abdominal and/or pelvic surgery EXCLUDING only ONE of the following&#xD;
             surgeries that was performed at least 12 months prior to study enrollment: cesarean&#xD;
             section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic&#xD;
             cholecystectomy. (For example: if a patient has had 2 cesarean sections, or one&#xD;
             cesarean section and a laparoscopic appendectomy, she would be excluded. If a patient&#xD;
             had one cesarean section, she may be included)&#xD;
&#xD;
          8. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous,&#xD;
             scleroderma) or immunocompromised&#xD;
&#xD;
          9. History of genetic or endocrine causes of obesity not adequately controlled by&#xD;
             medication&#xD;
&#xD;
         10. History of/or signs and/or symptoms of/or radiographic evidence of esophageal,&#xD;
             gastric, or duodenal disease including but not limited to hiatal hernias greater than&#xD;
             or equal to 2 centimeter (cm), paraesophageal hernias, inflammatory diseases, cancer,&#xD;
             varices, diverticula, gastroparesis, ulcers, stricture/stenosis, achalasia and&#xD;
             esophagitis&#xD;
&#xD;
         11. Insulin-dependent diabetes (either Type 1 or Type 2)&#xD;
&#xD;
         12. Significant acute and/or chronic infections of any kind&#xD;
&#xD;
         13. Severe coagulopathy, hepatic insufficiency or cirrhosis&#xD;
&#xD;
         14. Unable or unwilling to discontinue use of aspirin and/or non-steroidal&#xD;
             anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse Deployment and&#xD;
             continuing for 14 days after Elipse excretion&#xD;
&#xD;
         15. Currently taking the following medications (within 30 days prior to enrollment) and/or&#xD;
             there is a need or anticipated need for these medications during the study:&#xD;
&#xD;
             Excluded Medications:&#xD;
&#xD;
             Systemic corticosteroids Anticoagulant therapy (e.g. warafin, dabigatran) or&#xD;
             anti-platelet therapy) Immunosuppressive therapy (e.g. azathioprine, cyclosporine)&#xD;
             Prescription or over the counter weight loss medication(s) Medications known to cause&#xD;
             significant weight gain or weight loss Narcotics, opiates or benzodiazepines Insulin&#xD;
             for treatment of diabetes Anti-seizure therapy (e.g. clonazepam, phenytoin)&#xD;
             Anti-arrhythmics (e.g. amidarone)&#xD;
&#xD;
         16. History of pulmonary embolism&#xD;
&#xD;
         17. Has cardiac pacemaker or other electric implantable device&#xD;
&#xD;
         18. Anemia defined as either:&#xD;
&#xD;
               1. Hgb &lt; 11 for females, &lt;12 for males&#xD;
&#xD;
               2. Abnormal red cell indices and iron deficiency&#xD;
&#xD;
         19. Smoking cessation within 3 months of enrollment or plans to quit smoking during the&#xD;
             study&#xD;
&#xD;
         20. Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment&#xD;
&#xD;
         21. Residing in a location without ready access to study site medical resources&#xD;
&#xD;
         22. Inability to walk 200 yards without assistance&#xD;
&#xD;
         23. Eating disorders including night eating syndrome (NES), bulimia, or binge eating&#xD;
             disorder&#xD;
&#xD;
         24. Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affect&#xD;
             body weight during the study such as mammoplasty and lipoplasty&#xD;
&#xD;
         25. Current or history of illicit drug use or excessive alcohol use&#xD;
&#xD;
         26. Enrolled in another investigational study that has not completed the required primary&#xD;
             endpoint follow-up period (Note: Subjects involved in a long-term surveillance phase&#xD;
             of another study are eligible for enrollment in this study).&#xD;
&#xD;
         27. Any conditions that, in the opinion of the investigator, may render the subject unable&#xD;
             to complete the study with a likely fatal outcome, or lead to difficulties for subject&#xD;
             compliance with study requirements, or could confound study data.&#xD;
&#xD;
         28. Patient is not of sufficient medical health as determined by the Investigator to&#xD;
             participate in the study.&#xD;
&#xD;
         29. Employees/family members of Allurion Technologies or any of its affiliates or&#xD;
             contractors&#xD;
&#xD;
         30. Immediate employees/family members of the Investigator, sub-Investigators, or their&#xD;
             medical office or practice, or surgical, bariatric or hospital organizations at which&#xD;
             study procedures may be performed&#xD;
&#xD;
         31. An immediate family member (by marriage or blood relationship) of another subject&#xD;
             already enrolled in the study&#xD;
&#xD;
         32. Positive breath test for H. Pylori&#xD;
&#xD;
         33. History of or current inflammatory bowel disease (e.g. Crohn's disease, Ulcerative&#xD;
             Colitis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Honor Health</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado, Anschutz Health and Wellness Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bariatric Institute of Greater Chicago</name>
      <address>
        <city>Bolingbrook</city>
        <state>Illinois</state>
        <zip>60440</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Surgical Specialists of Louisiana</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holyoke Medical Center</name>
      <address>
        <city>Holyoke</city>
        <state>Massachusetts</state>
        <zip>01002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Medical Center (UPMC)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Metabolic and Bariatric Care</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidSouth Bariatrics</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Center for Surgical Weight Loss</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Physicians Minimally Invasive Surgeons of Texas (UTMIST)</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>May 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03261453
org study id: TRL-1000-0002
nct id: NCT03261453
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The primary objective of this study is to demonstrate the safety and efficacy of the Elipse
      Gastric Balloon System for the treatment of obese adults.
This is a prospective, double-blinded, randomized, two-phase study to be conducted in a
      planned 400 obese individuals drawn from up to 15 sites. The treatment duration of the study
      is 48 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks
time frame: 16 weeks
description: An inferential test of whether the Treatment Group Responder Rate (RR) dichotomized at 5% TBWL at 16 weeks is significantly greater than 35%.
measure: Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group
time frame: 16 weeks
description: An inferential test of whether the Treatment Group mean %TBWL is significantly greater than Control Group mean % TBWL at 16 weeks
measure: Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events
time frame: 24 weeks
description: The primary safety endpoint of this clinical investigation is the overall incidence of procedure- or device-related Serious Adverse Events through 24 weeks.
arm group label: Treatment
arm group type: Experimental
description: Patients randomized to treatment will receive the Elipse device.
arm group label: Control
arm group type: Sham Comparator
description: Patients randomized to the control arm will receive the sham device.
intervention type: Device
intervention name: Active Elipse Device
description: Intervention Device
arm group label: Treatment
other name: Elipse Gastric Balloon System (active)
intervention type: Device
intervention name: Elipse Sham Device
description: Control Device
arm group label: Control
other name: Elipse Gastric Balloon System (control)
criteria: 
gender: All
minimum age: 22 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
sharing ipd: Undecided