Pilot Trial of the Elipse™ Intragastric Balloon System for the Treatment of Overweight and Obese Individuals

Inclusion Criteria:

• Patient, female or male, 18 to 64 years of age.
• Patient must be able to understand and be willing to sign an IC document.
• Patient must be willing to participate in all aspects of the trial for the duration of the trial.
• Patient must be motivated to lose weight and have realistic expectations.
• Patient must complete the screening requirement to complete one week of Daily Eating Diaries and Daily Weight Logs.
• Patient must pass the Screening Behavioral Interview.
• Patient must understand that even though they undergo the Elipse™ Treatment, they must follow the physician guidelines for eating behaviors and lifestyle modifications for weight loss.
• Patient has a BMI of ≥ 27.0.
• Females must be willing to use contraception throughout the course of the trial until they exit.
• Patients must have a primary care physician that follows them for any co-morbid conditions.
• Patients must live within 160 kilometers of the trial site and not plan to move out of the vicinity for the trial duration.
• Patients must be fully ambulatory without any chronic orthopedic disease or reliance on crutches, walkers or a wheelchair that could preclude exercise during the trial.
• Patient must have a stable home environment that is supportive of the patient's efforts to lose weight.
• If Patient is an ex-smoker, they must be an ex-smoker for more than a year.
• Patient agrees to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty.

Exclusion Criteria:

• Patient has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
• Patient has pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to surgery), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
• Patient has had previous bariatric or gastric surgery.
• Patient has a history of acute pancreatitis.
• Patient has a history of small bowel obstructions.
• Patients with a history of abdominal and/or pelvic surgery EXCLUDING only ONE of the following surgeries that was performed at least 12 months prior to the Elipse™ Treatment: 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 they would be excluded. If a patient had one cesarean section they may be included.)
• Patient has history of/or signs and/or symptoms of esophageal, gastric, or duodenal disease including but not limited to hiatal hernias >2 centimeter (cm), inflammatory diseases, cancer, and varices.
• Patient has a specific diagnosed genetic or hormonal cause for obesity such as hypothyroidism or PraderWilli syndrome.
• Patient has poorly controlled diabetes.
• Patient has renal and/or hepatic insufficiency.
• Patient has systemic infection or abscess at the site to be treated.
• Patient is undergoing chronic steroid therapy.
• Patient is undergoing immunosuppressive therapy.
• Patient is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation.
• Patient is unable or unwilling to discontinue use of aspirin and/or non-steroidal anti-inflammatory agents (NSAIDs) at least 14 days prior to treatment and continuing for 14 days post-treatment.
• Patient has a history of pulmonary embolism or blood coagulation disorders.
• Patient is unable to discontinue either prescription or over the counter weight loss medications at least 30 days prior to treatment and continuing for the remainder of the trial
• Patient has cardiac pacemaker or other electric implantable device.
• Patient has a history of using any tobacco products including but not limited to cigars, cigarettes, and pipes within 12 months prior to enrollment.
• Patient has poorly controlled psychiatric disease such as depression.
• Patient has eating disorders including night eating syndrome (NES), Bulimia, or binge eating disorder, or who continuously graze on food for the majority of the day.
• Patient has uncontrolled life stressors at baseline such as divorce, or illness/death of personal acquaintances.
• Patient currently uses or has a history of illicit drug use or excessive alcohol use.
• Patient has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this trial, and does not agree to abstain from participation in other clinical trials of any kind during this trial.
• Patient is not of sufficient medical health as determined by the PI to participate in the trial.