Clinical trial NCT03261453: THE ENLIGHTEN STUDY
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Lead sponsor: Allurion Technologies
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 400
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 22 years and ≤ 65 years of age
2. BMI ≥30 kg/m2 and ≤ 40 kg/m2
3. Have signed study specific Informed Consent Form
4. Willing to comply with study requirements, including follow-up visits
5. Documented negative pregnancy test in women of childbearing potential.
6. 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).
7. Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study.
8. 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:

1. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
2. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer
3. Previous bariatric or gastric surgery or likely to undergo during study
4. Use of an intragastric device prior to this study
5. Chronic pancreatitis or acute pancreatitis within 12 months of enrollment
6. History of or current small bowel obstructions
7. 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)
8. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised
9. History of genetic or endocrine causes of obesity not adequately controlled by medication
10. 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
11. Insulin-dependent diabetes (either Type 1 or Type 2)
12. Significant acute and/or chronic infections of any kind
13. Severe coagulopathy, hepatic insufficiency or cirrhosis
14. 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
15. 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)
16. History of pulmonary embolism
17. Has cardiac pacemaker or other electric implantable device
18. Anemia defined as either:

    1. Hgb \< 11 for females, \<12 for males
    2. Abnormal red cell indices and iron deficiency
19. Smoking cessation within 3 months of enrollment or plans to quit smoking during the study
20. Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment
21. Residing in a location without ready access to study site medical resources
22. Inability to walk 200 yards without assistance
23. Eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
24. Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty
25. Current or history of illicit drug use or excessive alcohol use
26. 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).
27. 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.
28. Patient is not of sufficient medical health as determined by the Investigator to participate in the study.
29. Employees/family members of Allurion Technologies or any of its affiliates or contractors
30. 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
31. An immediate family member (by marriage or blood relationship) of another subject already enrolled in the study
32. Positive breath test for H. Pylori
33. History of or current inflammatory bowel disease (e.g. Crohn's disease, Ulcerative Colitis)

Primary outcomes:
measure: Co-Primary Effectiveness Endpoint: Total Body Weight Loss (TBWL) Comparison Between Treatment and Control Group at 16 weeks
timeFrame: 16 weeks
measure: Co-Primary Effectiveness Endpoint 2: Percent of Total Body Weight Loss (TBWL) Comparison Between Treatment and Control group
timeFrame: 16 weeks
measure: Primary Safety Endpoint: Incidence of overall procedure or device related Serious Adverse Events
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Aurora
country: United States
facility: University of Colorado, Anschutz Health and Wellness Center
state: Colorado
city: Bolingbrook
country: United States
facility: Bariatric Institute of Greater Chicago
state: Illinois
city: Metairie
country: United States
facility: Surgical Specialists of Louisiana
state: Louisiana
city: Holyoke
country: United States
facility: Holyoke Medical Center
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism
state: New York
city: Pittsburgh
country: United States
facility: University of Pennsylvania Medical Center (UPMC)
state: Pennsylvania
city: Chattanooga
country: United States
facility: CHI Metabolic and Bariatric Care
state: Tennessee
city: Memphis
country: United States
facility: MidSouth Bariatrics
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Center for Surgical Weight Loss
state: Tennessee
city: Bellaire
country: United States
facility: UT Physicians Minimally Invasive Surgeons of Texas (UTMIST)
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center
state: Virginia
Study officials:
References: