The IGBallon (R) - for Use in the Treatment of Obesity

Prior treatment

• Previous gastric surgery affecting the esophagus, stomach, or pylorus that would interfere with ingestion or placement of the IGBalloon.
• Debilitating comorbidities preventing surgery.
• Gastro-esophageal reflux resistant to proton pump inhibitors.
• Previously diagnosed with Cushing's disease and/or hypothyroidism.
• Likely to require abdominal surgery during the study period.
• 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.)
• 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:
• Hormonal contraceptive, if used for at least 3 months prior to study.
• 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.

Other illness

• 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.
• Malignant disease.
• Insulin-dependent diabetes mellitus.

Other

• Severely obese (BMI \> 45) or \>120 kg.
• Upper-GI abnormalities or anatomical variants likely to interfere with the study procedure.
• Symptomatic documented hiatal hernia.
• Life expectancy of less than 2 years.
• Participation in another clinical trial investigating a therapeutic device or medicine.
• 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.
• Intrauterine device (IUD).
• Condom and spermicide.
• Diaphragm and spermicide.
• Abstinence.

• 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.