Safety and Effectiveness of Orbera365™ Intragastric Balloon System

Launched by BOSTON SCIENTIFIC CORPORATION · Jul 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of the Orbera365™ Intragastric Balloon System, a weight loss device designed to help people with obesity. The balloon is placed inside the stomach to help reduce food intake and support weight loss. This study is being done in several centers across the European Union and will collect information from people who have already decided to use this balloon as part of their weight management plan.

People eligible to take part are adults aged 18 or older who have a body mass index (BMI) between 30 and 50, meaning they are classified as obese, or those with a BMI of 35 or higher who have related health problems. Participants should be able to understand and agree to the study details. During the time the balloon is inside the stomach, participants will have regular check-ups as part of their usual care, and then one final visit about a month after the balloon is removed. It’s important to know that some people won’t be able to join the study, such as those planning to become pregnant soon, those who can’t take certain medications needed during the treatment, or those with specific health conditions affecting the stomach or digestive tract. This study aims to better understand how well the Orbera365™ balloon works and how safe it is for people trying to lose weight.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is ≥ 18 years of age
• • 2. 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.
• • 3. Subject is able to read, understand, and sign a written Informed Consent Form to participate in the registry
• Exclusion Criteria:
• • 1. Subject is planning on becoming pregnant during the one year following study device placement
• • 2. Subject will complete follow-up visits at a location that the treating physician does not practice
• • 3. Subjects who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
• • 4. Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss supplements/medications.
• 5. 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