THE ENLIGHTEN STUDY

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Multi-Center, Phased, Pivotal Safety and Efficacy Study Comparing the Elipse™ Gastric Balloon System vs. Sham for the Treatment of Obese Adults

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Device: Active Elipse Device
* Device: Elipse Sham Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 22 years and ≤ 65 years of age BMI ≥30 kg/m2 and ≤ 40 kg/m2 Have signed study specific Informed Consent Form Willing to comply with study requirements, including follow-up visits Documented negative pregnancy test in women of childbearing potential. Women of childbearing potential not intending to become pregnant for the duration of study participation. (Note: Women of childbearing potential must not be nursing at the time of treatment). Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study. Confirmed unsuccessful attempts at more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs attempted within the 24 months preceding enrollment. Exclusion Criteria: Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer Previous bariatric or gastric surgery or likely to undergo during study Use of an intragastric device prior to this study Chronic pancreatitis or acute pancreatitis within 12 months of enrollment History of or current small bowel obstructions History of abdominal and/or pelvic surgery EXCLUDING only ONE of the following surgeries that was performed at least 12 months prior to study enrollment: cesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy. (For example: if a patient has had 2 cesarean sections, or one cesarean section and a laparoscopic appendectomy, she would be excluded. If a patient had one cesarean section, she may be included) Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised History of genetic or endocrine causes of obesity not adequately controlled by medication History of/or signs and/or symptoms of/or radiographic evidence of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias greater than or equal to 2 centimeter (cm), paraesophageal hernias, inflammatory diseases, cancer, varices, diverticula, gastroparesis, ulcers, stricture/stenosis, achalasia and esophagitis Insulin-dependent diabetes (either Type 1 or Type 2) Significant acute and/or chronic infections of any kind Severe coagulopathy, hepatic insufficiency or cirrhosis Unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to Elipse Deployment and continuing for 14 days after Elipse excretion Currently taking the following medications (within 30 days prior to enrollment) and/or there is a need or anticipated need for these medications during the study: Excluded Medications: Systemic corticosteroids Anticoagulant therapy (e.g. warafin, dabigatran) or anti-platelet therapy) Immunosuppressive therapy (e.g. azathioprine, cyclosporine) Prescription or over the counter weight loss medication(s) Medications known to cause significant weight gain or weight loss Narcotics, opiates or benzodiazepines Insulin for treatment of diabetes Anti-seizure therapy (e.g. clonazepam, phenytoin) Anti-arrhythmics (e.g. amidarone) History of pulmonary embolism Has cardiac pacemaker or other electric implantable device Anemia defined as either: Hgb < 11 for females, <12 for males Abnormal red cell indices and iron deficiency Smoking cessation within 3 months of enrollment or plans to quit smoking during the study Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment Residing in a location without ready access to study site medical resources Inability to walk 200 yards without assistance Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty Current or history of illicit drug use or excessive alcohol use Enrolled in another investigational study that has not completed the required primary endpoint follow-up period (Note: Subjects involved in a long-term surveillance phase of another study are eligible for enrollment in this study). Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study with a likely fatal outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data. Patient is not of sufficient medical health as determined by the Investigator to participate in the study. Employees/family members of Allurion Technologies or any of its affiliates or contractors Immediate employees/family members of the Investigator, sub-Investigators, or their medical office or practice, or surgical, bariatric or hospital organizations at which study procedures may be performed An immediate family member (by marriage or blood relationship) of another subject already enrolled in the study Positive breath test for H. Pylori History of or current inflammatory bowel disease (e.g. Crohn's disease, Ulcerative Colitis)

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients randomized to treatment will receive the Elipse device. | Device: Active Elipse Device<br>* Intervention Device<br>* Other names: Elipse Gastric Balloon System (active);|
| Sham Comparator: Control<br>Patients randomized to the control arm will receive the sham device. | Device: Elipse Sham Device<br>* Control Device<br>* Other names: Elipse Gastric Balloon System (control);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks | An inferential test of whether the Treatment Group Responder Rate (RR) dichotomized at 5% TBWL at 16 weeks is significantly greater than 35%. | 16 weeks | 
| Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group | An inferential test of whether the Treatment Group mean %TBWL is significantly greater than Control Group mean % TBWL at 16 weeks | 16 weeks | 
| Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events | The primary safety endpoint of this clinical investigation is the overall incidence of procedure- or device-related Serious Adverse Events through 24 weeks. | 24 weeks |