Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
This study is checking a new medical device called RefluxStop, which is used to treat long-lasting acid reflux and heartburn (Gastro-oesophageal Reflux Disease or GERD). It's a 'post-market registry', meaning the device is already available, and this study collects more information on its safety and how well it performs in real-world use. Researchers will compare it to a common surgery for reflux called Nissen fundoplication. The main goal is to understand if RefluxStop is a safe and effective treatment choice for people struggling with GERD who are looking for clearer answers about their options.
At a glance
What is this study about?
This registry is looking at a treatment for a common problem called GORD (Gastro-oesophageal Reflux Disease). GORD is when stomach acid repeatedly flows back up into the gullet (oesophagus), causing heartburn and other uncomfortable symptoms. If medicines don't fully help, surgery might be an option.
One new treatment being looked at is a device called RefluxStop. This study is collecting information on how well RefluxStop works and how safe it is for people in everyday medical care, comparing it to a standard surgery for GORD called Nissen fundoplication. It's a little like keeping a close eye on a new car model after it's been sold to see how it performs with many different drivers over time.
The main aim is to get a clearer picture of how RefluxStop helps people manage their GORD symptoms and improve their quality of life, while also making sure it's safe. This information will help doctors and patients make informed decisions about the best treatment options for GORD.
Key takeaways
- This study is gathering real-world information on a device called RefluxStop for acid reflux.
- It compares RefluxStop with a common surgery for reflux, Nissen fundoplication.
- The aim is to understand both safety and how well RefluxStop works for patients.
- Your standard medical check-ups will be used to collect study information.
- This research helps improve treatment choices for people with GORD.
Who may be eligible?
To join this study, you must be at least 18 years old and agree to take part. You need to have had GORD symptoms, like heartburn, for more than six months. Doctors will need to confirm your GORD using a special 24-hour test that measures acid in your gullet.
You also need to be well enough to have a general anaesthetic and keyhole surgery, as decided by the study doctor. There are some reasons why you couldn't take part, for example, if you have a very large hernia near your gullet, have had certain stomach surgeries in the past, or if you are pregnant or breastfeeding.
Also, if you're allergic to silicone (a material often used in medical devices) or if the doctors think you wouldn't be able to follow the study's instructions, you wouldn't be able to join.
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 or older?
- Have you had GORD symptoms for more than 6 months?
- Have you had a 24-hour test to confirm acid reflux?
- Are you generally healthy enough for surgery?
- Are you not pregnant or breastfeeding?
What does participation involve?
This study is a registry, which means it will collect information about your treatment with RefluxStop or traditional surgery as part of your standard medical care. You won't be involved in extra appointments just for the study, but your doctors will collect specific information about your health, symptoms, and how well the treatment is working during your regular check-ups. The total length of your participation would depend on how long your doctor typically monitors patients after this type of procedure, as it's part of your ongoing care.
Potential risks and benefits
Locations (6)
- Klinikum Friedrichshafen GmbHVerified postcodeFriedrichshafen, Germany· Active not recruiting
- Ospedale IRCCS Saverio De BellisVerified postcodeBari, Italy· Recruiting
- Ospedale Buon Consiglio FatebenefratelliVerified postcodeNaples, Italy· Recruiting
- Akershus Universitetssykehus HFCity onlyLørenskog, Norway· Recruiting
- Inselspital, Universitätsspital BernVerified postcodeBern, Switzerland· Recruiting
- Hirslanden KlinikVerified postcodeBern, Switzerland· Recruiting
Common questions
What is GORD?
GORD (Gastro-oesophageal Reflux Disease) is a condition where stomach acid frequently comes back up into your food pipe (gullet), causing symptoms like heartburn and indigestion.
What is RefluxStop?
RefluxStop is a medical device designed to help treat longstanding acid reflux when other treatments haven't worked well.
What is Nissen fundoplication?
Nissen fundoplication is a type of surgery often performed for GORD, where the top part of the stomach is wrapped around the lower gullet to strengthen the valve between them.
Will I have to take extra medicines for this study?
No, this study doesn't involve taking extra medicines. It monitors the effects of RefluxStop or standard surgery, which are treatments for GORD.
How long does the study last?
Because it's a registry study, your participation timeframe will align with your routine medical follow-up after your procedure, which your doctor can explain.
How to find out more
Souheila Moutiq
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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