Swallowable balloon aims to help obese patients shed pounds

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Body Mass Index (BMI) greater than 35 or greater than 30 with comorbidities (type 2 diabetes, dyslipidemia, hypertension, obstructive sleep apnea, osteoarthritis, or coronary heart disease). * Male or female participants aged between 18-70 years and representative of the general population. * Availability for the entire study period, and willingness to adhere to protocol requirements as evidenced by giving signed informed consent. * Failure at previous attempts at weight loss through diet, exercise, and/or behavior modification. Exclusion Criteria: * Severely obese (BMI \> 45) or \>120 kg. * Previous gastric surgery affecting the esophagus, stomach, or pylorus that would interfere with ingestion or placement of the IGBalloon. * Debilitating comorbidities preventing surgery. * Inflammatory disease of the gastrointestinal (GI) tract. * Upper-GI bleeding conditions. * History of gastrointestinal ulcers or bleeding. * Existing gallbladder disease. * Positive breath test for the presence of H. pylori infection. * Gastro-esophageal reflux resistant to proton pump inhibitors. * Previously diagnosed with Cushing's disease and/or hypothyroidism. * Malignant disease. * Likely to require abdominal surgery during the study period. * Upper-GI abnormalities or anatomical variants likely to interfere with the study procedure. * Symptomatic documented hiatal hernia. * Insulin-dependent diabetes mellitus. * Life expectancy of less than 2 years. * Participation in another clinical trial investigating a therapeutic device or medicine. * Major prior or present psychological or psychiatric disorder (including a history of drug and/or alcohol addiction, severe depression, Electroconvulsive Therapy (ECT) treatment - current or recent.) * Inability to tolerate blood draws. * Inability or unwillingness to swallow large items after coaching in swallowing technique. * If female, lactating or positive pregnancy test at screening or before each of the treatment periods. * If female and of child-bearing potential, unwillingness to abstain from sexual intercourse or use a medically acceptable method of contraception from 14 days before the study and throughout the entire study period. Acceptable methods of contraception: 1. Hormonal contraceptive, if used for at least 3 months prior to study. 2. Intrauterine device (IUD). 3. Condom and spermicide. 4. Diaphragm and spermicide. 5. Abstinence. 6. Surgical sterilization of either partner. * Previously defined non-compliance with prescribed medical care. * Identified eating disorder likely to significantly increase risk of complication. * Prior enrolment in this study.