A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice
This study is gathering information on a new treatment called RefluxStop™ for people with severe heartburn and acid reflux (Gastroesophageal Reflux Disease, known as GERD). It's a 'post-market' study, meaning the device is already in use, and doctors are now carefully tracking its performance and safety in real-world hospital settings. They are collecting information from patients who have the RefluxStop™ device implanted. The main goal is to understand how well the device works and to make sure it's safe for patients over a long period. Patients will have regular check-ups after their surgery, lasting up to 7 years. This helps doctors learn more about the long-term effects of the treatment.
At a glance
What is this study about?
This study is all about a device called RefluxStop™, which is used to help people who suffer from a common and often uncomfortable condition called GERD – that's Gastroesophageal Reflux Disease. You might know it better as severe heartburn or acid reflux. When you have GERD, stomach acid regularly travels back up into your food pipe, causing burning pain and other symptoms.
The RefluxStop™ device is already available for use, but doctors want to learn even more about how it works in real-life situations. This is why they are running this study, which is like a detailed observation. They are carefully watching how patients who receive the RefluxStop™ device get on, keeping track of their symptoms, how well the device helps them, and whether there are any problems.
The main purpose of this research is to collect very important information about the RefluxStop™ device's safety and how well it helps control GERD symptoms over several years. This helps healthcare professionals and patients make informed decisions about treatment options for reflux.
Key takeaways
- This study is about the RefluxStop™ device for severe heartburn and acid reflux.
- It aims to track the device's safety and effectiveness in general hospital practice.
- Patients will have surgery to implant the device.
- Follow-up check-ups will last for up to 7 years.
- You must meet specific health criteria to be eligible.
- Participation helps improve understanding of this treatment.
Who may be eligible?
To join this study, you would need to be an adult, at least 18 years old, and be happy to give your permission to take part. A doctor would need to confirm that you have had GERD (heartburn or acid reflux) for at least 6 months and that it has been properly diagnosed using special tests.
You would also need to be well enough to have a general anaesthetic and keyhole surgery, as decided by the doctor running the study. They will check all your health details to make sure the RefluxStop™ treatment is right for you.
There are also some reasons why you might not be able to join. For example, if you have a very large hiatus hernia (over 8cm), certain stomach problems like very slow stomach emptying, or if you've had certain types of weight-loss surgery. Women who are pregnant, or people with known allergies to silicone, would also not be able to participate. Finally, if doctors think you wouldn't be able to keep up with the study's requirements, you might not be suitable.
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 been diagnosed with ongoing heartburn or reflux for at least 6 months?
- Are you able to have general anaesthesia and keyhole surgery?
- Are you not pregnant?
- Do you not have a very large hiatus hernia (over 8cm)?
- Are you not allergic to silicone materials?
What does participation involve?
If you join this study, you will have the RefluxStop™ device implanted during keyhole surgery under general anaesthetic. After your surgery, doctors will want to check on your progress and the device's performance. You'll have follow-up appointments at 3 months and 6 months after the operation. After that, you'll have annual check-ups once a year for up to 7 years. These visits are important for gathering information about how you're feeling and how the device is working over the long term. You won't be given any new or experimental medications as part of this study; it focuses on the device itself and your usual clinical care.
Potential risks and benefits
Locations (5)
- Klinikum Friedrichshafen GmbHVerified postcodeFriedrichshafen, Germany
- H. Universitario GetafeVerified postcodeGetafe, Spain
- H. La Mancha CentroVerified postcodeAlcázar de San Juan, Spain
- H. Infanta SofíaVerified postcodeMadrid, Spain
- H. Ramón y CajalVerified postcodeMadrid, Spain
Common questions
What is GERD?
GERD stands for Gastroesophageal Reflux Disease, which is a common condition where stomach acid frequently flows back into the food pipe, causing symptoms like heartburn.
What is RefluxStop™?
RefluxStop™ is a small device that is implanted during surgery to help treat severe heartburn and acid reflux by stopping stomach acid from travelling up the food pipe.
Why is this study being done if the device is already available?
This study helps doctors gather more detailed information about how well RefluxStop™ works and its safety in real patients over a long period, helping them understand its effects outside of initial trials.
How long will I be followed up in this study?
If you join, you will have follow-up appointments for up to 7 years after your surgery to check on your progress and the device.
Will I have to take new medicines for this study?
No, this study focuses on the RefluxStop™ device itself. You won't be given any new or experimental medications as part of the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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