THE ENLIGHTEN STUDY

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT03261453

Run by

Allurion Technologies

People needed

400

Starts

2018-02-01

Expected to finish

2019-05-01

Last updated by the study team

2024-02-02

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Honor Health — Scottsdale, Arizona, United States
• University of Colorado, Anschutz Health and Wellness Center — Aurora, Colorado, United States
• Bariatric Institute of Greater Chicago — Bolingbrook, Illinois, United States
• Surgical Specialists of Louisiana — Metairie, Louisiana, United States
• Holyoke Medical Center — Holyoke, Massachusetts, United States
• Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism — New York, New York, United States
• University of Pennsylvania Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• CHI Metabolic and Bariatric Care — Chattanooga, Tennessee, United States
• MidSouth Bariatrics — Memphis, Tennessee, United States
• Vanderbilt Center for Surgical Weight Loss — Nashville, Tennessee, United States
• UT Physicians Minimally Invasive Surgeons of Texas (UTMIST) — Bellaire, Texas, United States
• Charlottesville Medical Research Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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