RecruitingNCT07062094

Safety and Effectiveness of Orbera365™ Intragastric Balloon System

Safety and Effectiveness of Orbera365™ Intragastric Balloon System: A Multi-Center, Prospective, Standard of Care Registry

Sponsor

Boston Scientific Corporation

Enrollment

200 participants

Start Date

Apr 7, 2026

Study Type

OBSERVATIONAL

Conditions

Obesity

Summary

This is a prospective, multi-center, standard of care registry offered to subjects in the EU only that have already agreed to receive the Orbera365™ Intragastric Balloon (IGB) System for weight loss. Subjects that agree to participate in the registry will have data reported associated with standard of care weight management visits during the time the device is implanted (in-dwell period), with an additional visit 30 days after the removal procedure.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria15

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
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

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Interventions

DEVICEIntragastric Balloon

The Orbera365™ IGB System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight loss maintenance. The IGB is placed in the stomach and filled with sterile saline, causing it to expand into a spherical shape. The filled IGB is designed to occupy space and move freely within the stomach, potentially altering appetite and satiety to achieve weight loss.