Safety and Effectiveness of Orbera365™ Intragastric Balloon System

Korábbi kezelés

• Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.
• Subjects who have conditions that are contraindicated for Orbera365™ IGB System as per the IFU, including, but not limited to:
  • The presence of more than one IGB at the same time.
  • Any inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
  • Potential upper gastrointestinal bleeding conditions
  • A large hiatal hernia of > 5cm or a hernia ≤ 5 cm associated with severe or intractable gastro- esophageal reflux symptoms
  • A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the delivery catheter and/or an endoscope
  • Achalasia, symptoms suggestive of delayed gastric emptying, or presence of any other severe motility disorder that that may pose a safety risk during placement or removal of the device.
  • Gastric Mass.
  • Severe coagulopathy.
  • Taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants and not under medical supervision.
  • Prior surgery involving the esophagus, stomach, and duodenum or bariatric surgery

Egyéb

• Subject is planning on becoming pregnant during the one year following study device placement
• Subject will complete follow-up visits at a location that the treating physician does not practice

• Subject is ≥ 18 years of age
• Subject meets the indicated population for the device according to the Instructions for Use (IFU) including obese patients with the BMI of 30-50 kg/m2 for weight loss and patients with BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities before obesity or another surgery, unless contraindicated.
• Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry