Safety and Effectiveness of Orbera365™ Intragastric Balloon System
This study is about a special balloon, called the Orbera365™ Intragastric Balloon, used to help people with obesity lose weight. If you've already decided with your doctor to get this balloon, you might be asked to join. The main goal is to check how safe and effective the balloon is when it stays inside your stomach for a longer period, up to 12 months. Doctors will use information they already collect from your usual check-ups. This helps them understand more about how the balloon works and if it's safe for extended use. It's for adults across Europe who have tried other weight loss methods without success, or who need to lose weight before surgery.
At a glance
What is this study about?
This study, called a registry, is looking closely at the Orbera365™ Intragastric Balloon. This balloon is a device placed into your stomach to help you feel fuller and eat less, leading to weight loss. The main purpose of this study is to see how safe this balloon is when it stays in your stomach for a longer time than usual – specifically, for up to 12 months instead of the typical 6 months. By collecting information from people who are already getting the balloon as part of their standard care, the researchers hope to confirm its safety for this extended use.
Researchers are particularly interested in people who are obese, meaning they have a high Body Mass Index (BMI). This study is for those who have already tried other weight loss plans that didn't work for them. It also includes people who need to lose a significant amount of weight before having other surgeries, as this can make surgery safer for them. Up to 200 people from different locations in Europe will be included, allowing doctors to gather enough information.
Essentially, this study is about checking that the Orbera365™ Intragastric Balloon remains a safe option for patients when used for a longer duration, helping more people achieve their weight loss goals in a trusted way.
Key takeaways
- This study evaluates the safety of the Orbera365™ intragastric balloon for up to 12 months.
- It's for adults with obesity who are already scheduled to receive the balloon.
- Data will be collected from routine doctor visits, no extra medical tests are required by the study.
- The study helps doctors understand long-term balloon use for weight loss.
- Participation lasts up to 13 months, including a follow-up after balloon removal.
Who may be eligible?
To be part of this study, you must be at least 18 years old. You should have already decided with your doctor to have the Orbera365™ Intragastric Balloon placed, and it must be suitable for your situation based on the manufacturer's guidelines. This typically means you are obese (with a BMI between 30 and 50) and have previously found it hard to lose or keep off weight with other supervised programmes. If you have a very high BMI (40 or above), or a BMI of 35 or above with other health issues, and need to lose weight before surgery, you might also be suitable.
There are also some reasons why you wouldn't be able to join. For example, if you plan to become pregnant within a year of having the balloon placed, or if you can't or won't take certain medications to protect your stomach while the balloon is in. You also won't be able to join if you have certain digestive conditions or issues with your stomach or throat, or if you are currently taking specific medications like blood thinners or anti-inflammatory drugs that could increase risks.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you already discussed and agreed with your doctor to get the Orbera365™ balloon?
- Are you able and willing to take stomach protection medication as prescribed?
- Do you plan to avoid becoming pregnant in the next year?
What does participation involve?
If you decide to take part, you'll be involved for up to 13 months. This includes the time the balloon is in your stomach (up to 12 months) and a follow-up visit about a month after it's removed. The study will mainly collect information from your regular check-ups with your doctor while the balloon is in place. You will need to take medications to protect your stomach, as prescribed by your doctor, for as long as the balloon is implanted. You'll also have a final assessment about 30 days after the balloon is taken out. Apart from these visits, your treatment will be as normal for someone with the Orbera365™ balloon.
Potential risks and benefits
Locations (5)
- OB KlinikaVerified postcodePrague, Czechia· Recruiting
- Hôpital AvicenneVerified postcodeBobigny, France· Not yet recruiting
- EndoBes - Centre Medico TeknonVerified postcodeBarcelona, Spain· Recruiting
- Dorsia Clinic, Madrid SpainVerified postcodeMadrid, Spain· Not yet recruiting
- UHCW NHS TrustVerified postcodeCoventry, United Kingdom· Not yet recruiting
Common questions
What is the Orbera365™ Intragastric Balloon?
It's a soft, silicone balloon placed in your stomach to help you feel full, so you eat less and lose weight.
Why is this study being done?
To check if the Orbera365™ balloon is still safe and effective when it stays in your stomach for a longer time, up to a year.
Do I get special treatment in this study?
No, you'll receive the same care as anyone else getting the Orbera365™ balloon. The study just collects information from your usual visits.
How long will I be in the study?
Up to 13 months. This covers the time the balloon is in (up to 12 months) and a check-up about a month after it's removed.
Can I leave the study at any time?
Yes, you can choose to stop participating at any point, and your medical care will not be affected.
How to find out more
Shay Caravaggio
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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