Gastric On in Obesity Management: Evaluation of the Safety and Efficacy of the 6-Month Gastric Balloon (Prospective)

Prior treatment

• Prior gastrointestinal surgery.
• Alcoholism or drug addiction.
• Individuals who are unwilling or unable to take prescribed proton pump inhibitor medication for the duration of device placement.
• Individuals taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants on a daily basis who are not taking these medications under medical supervision.
• Prior (within 60 days of study day 1) or ongoing participation in a clinical trial, or current or prior use of an investigational drug or device (within 60 days of study day 1), or use of any intragastric balloon prior to this study.
• Prior bariatric surgery, or considering bariatric surgery during the study.
• Concomitant use of weight-loss medications, weight-loss supplements or herbal weight-loss preparations, or unwillingness to refrain from their use.

Other illness

• Any inflammatory disease of the gastrointestinal (GI) tract, including specific inflammation such as esophagitis, gastric ulcer, duodenal ulcer, cancer or Crohn's disease.
• Any potential gastrointestinal bleeding condition, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia, or other congenital anomalies of the GI tract such as atresia or stenosis.
• Any other severe motility disorder that could pose a safety risk during removal of the device.
• Presence of hepatic insufficiency or cirrhosis.
• Any other medical condition that would preclude elective endoscopy, such as poor general health or a history and/or symptoms of severe renal, hepatic, cardiac and/or pulmonary disease.
• Serious or uncontrolled psychiatric illness or disorder that could compromise the participant's understanding of follow-up visits or compliance with device removal after 6 months.
• Women who are pregnant, breastfeeding or planning to become pregnant within the next year; known or suspected allergy to materials contained in the GastricOn 6-Month Gastric Balloon.
• Presence of any condition or circumstance that, in the opinion of the investigator, could place the participant at significant risk or substantially interfere with the participant's participation in the study.

Other

• Presence of more than one intragastric balloon at the same time.
• A large hiatal hernia (greater than 5 cm), or a hiatal hernia of 5 cm or less associated with severe or intractable gastroesophageal reflux symptoms.
• Structural abnormalities of the esophagus or pharynx, such as stricture or diverticulum, that could impede passage of the delivery catheter and/or endoscope.
• Presence of a gastric mass.
• Presence of severe coagulopathy.
• Individuals who do not agree to participate in an institutionally supervised diet and behavioral modification program with regular medical follow-up.
• Obesity of genetic origin.

• Age ≥18 and ≤60 years.
• BMI ≥30 kg/m² and ≤40 kg/m².
• History of obesity (BMI ≥30 kg/m²) for at least 2 years.
• Prior attempt at more conservative weight-loss alternatives, such as supervised diet, exercise and behavioral modification programs.
• Agreement to participate in a supervised diet and behavioral modification program designed to enhance long-term weight-loss maintenance.
• Willingness to comply with the requirements specified in the protocol, including adherence to the visit schedule.
• Ability to provide written informed consent.