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Stomach balloon study aims to help people with obesity shed pounds safely

NCT ID NCT07062094

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This study tracks 200 adults with obesity in the EU who choose to get the Orbera365 intragastric balloon. The balloon is placed in the stomach and filled with saline to help people feel full and eat less. Researchers will monitor serious side effects and how much weight participants lose over up to 12 months with the balloon in place.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
intragastric balloon (Orbera365)
What this could lead to
If successful, this could confirm that the Orbera365 balloon is a safe and effective tool for significant weight loss in people with obesity.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. Risks include serious complications like blockage or balloon deflation requiring hospital care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include Obese patients (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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dorsia Clinic, Madrid Spain

    RECRUITING

    Madrid, Spain

  • EndoBes - Centre Medico Teknon

    RECRUITING

    Barcelona, Spain

  • OB Klinika

    RECRUITING

    Prague, Czechia

  • UHCW NHS Trust

    NOT_YET_RECRUITING

    Coventry, West Midlands, CV2 2DX, United Kingdom

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