THE ENLIGHTEN STUDY

Allurion

Status

Completed

Conditions

Overweight

Obesity

Treatments

Device: Active Elipse Device

Device: Elipse Sham Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03261453

TRL-1000-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

All

Ages

22 to 65 years old

Volunteers

No Healthy Volunteers

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:
1. Hgb < 11 for females, <12 for males
2. 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)