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Safety and Effectiveness of Orbera365™ Intragastric Balloon System

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Intragastric Balloon (device)
How long the study runs: Study runs about 25 months (dates as stated)
About the drug or intervention: Intragastric Balloon — device: 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.
Patient visit burden: Not specified by the sponsor

Type of study: Observing health over time
Ages: 18 Years and over
Who: All
Number of participants: 200
Started: 2026-04-07
Last checked: 2026-10

Plain English Summary

What is this study?

• Testing a new treatment for obesity
• Clinical study - 200 participants
• 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

Who can take part?

• Ages 18 Years and over
• Diagnosed with obesity

Where?

• Coventry - UHCW NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

The study's objective is to confirm the safety of the Orbera365™ Intragastric Balloon (IGB) for extended in situ dwell time (from 6 months up to 12 months). This information can be collected from standard-of-care data. Up to ten (10) sites located in Europe are planned to participate in this registry. A minimum of 100 subjects are required for the registry. A maximum of 200 subjects may be enrolled into the registry. The study population will include Obese patients ((Body Mass Index (BMI) 30-50 kg/m2)) who have already consented to receive the Orbera365™ IGB System, who previously failed to achieve and maintain weight loss with a supervised weight-control program. Study subjects will also include obese and super obese patients (BMI 40 kg/m2 and above or a BMI of 35 kg/m2 with comorbidities) prior to obesity or other surgery, in order to reduce surgical risk. The duration of study participation is expected to be up to thirteen months from study placement procedure. The total treatment with the study device will be no more than 12 months from placement. A 30-day post-removal assessment will be performed following the study removal procedure. The subject will have completed the study upon the completion of the 30-day post-removal assessment, regardless of when the study removal procedure occurred.

Obesity

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

What the study is looking for

✓Subject is ≥ 18 years of age
✓Subject is able to read, understand, and sign a written agreement to take part Form to participate in the registry

Who cannot take part

✗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...
✗Current use or use within the three months before the baseline visit of over-the-counter or prescribed weight loss...
✗Subjects who have conditions that are not safe to use for Orbera365™ IGB System as per the IFU, including, but not...

See the full 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

Where Is This Study? (1 UK site)

UHCW NHS Trust

Coventry CV2 2DX, United Kingdom

NOT_YET_RECRUITING

Site contact (verified)

Vinod Menon, Prof.Principal Investigator

How to Get in Touch

Shay Caravaggio

Sponsor contact

CONTACT

(508) 683-4000 shay.caravaggio@bsci.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-10