Active not recruitingOBSERVATIONAL

RETHINK REFLUX Registry

This research, called the RETHINK REFLUX Registry, is studying people who have a special device called the LINX Reflux Management System fitted for their acid reflux. The main goal is to check how safe the LINX device and the fitting procedure are over a long period, up to 10 years after it's put in. Researchers are also looking at how well the device helps with reflux symptoms and the overall cost and use of healthcare by patients. This study will follow new patients aged 21 and older who are planning to have the LINX device fitted at various hospitals in the UK and other countries. If you're interested, you'll need to be willing to answer questions electronically.

At a glance

Status

Active not recruiting

Sponsor

Ethicon Endo-Surgery

Enrolment target

500

Start

08 Jul 2020

Estimated completion

31 Jul 2032

Gastroesophageal Reflux

What is this study about?

This study, called the RETHINK REFLUX Registry, is looking closely at the LINX Reflux Management System. This system is a treatment designed to help people who suffer from acid reflux, where stomach acid rises into the gullet, causing heartburn and other uncomfortable symptoms. The LINX device is a small ring of magnetic beads placed around the lower part of the gullet to help keep it closed and prevent acid from escaping.

The main purpose of this registry is to track how safe the LINX device is over a long time. The researchers want to understand if there are any side effects or problems that might appear many years after the device has been put in. They will follow people for up to 10 years, collecting information about their health and how they are feeling.

This isn't a study where doctors are trying out a new treatment; instead, it's about watching how a treatment already available works in real patients. By collecting this information, they hope to get a very clear picture of the device's long-term safety and how well it helps people manage their reflux symptoms, which can ultimately help doctors and patients make better choices about treatment.

Key takeaways

This study tracks the long-term safety of the LINX device for acid reflux.
It follows patients for up to 10 years after the device is put in.
You must be 21 or older and planning to have the LINX procedure.
Participation involves electronic surveys and regular health checks.
The aim is to understand how well the LINX device works over time and any side effects.

Who may be eligible?

To be part of this study, you need to be at least 21 years old. A key requirement is that you must be planning to have the LINX device fitted for your acid reflux. You'll also need to agree to take part by signing a consent form and be comfortable filling in questionnaires and surveys on a computer or other electronic device.

However, you can't join if you've already had a LINX device fitted before. Also, if your doctor believes that, for any medical reason or because you have a condition that might shorten your life significantly (less than 10 years), you wouldn't be able to stay in the study for the full 10 years, then you wouldn't be able to participate. The study needs people who are healthy enough to be followed for a long time.

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 21 years old or older?
Are you planning to have the LINX device fitted for your acid reflux?
Are you willing to sign a consent form to join the study?
Are you comfortable filling out surveys on a computer or tablet?
Have you NOT had a LINX device fitted before?
Do you expect to be able to stay in touch for at least 10 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll be doing is having the LINX device fitted as planned by your doctor. After the device is in, the study involves regular check-ups where medical staff will monitor your health and how the device is working. You will also be asked to complete questionnaires and surveys electronically. These surveys will ask about your symptoms, your general health, and how the LINX device is affecting your daily life. These updates will happen at different points over the 10 years following your procedure, allowing the researchers to track your progress and any changes. There isn't any extra medication involved, just regular follow-up and sharing your experiences.

Potential risks and benefits

Taking part in this study could offer the benefit of contributing valuable information that helps doctors understand the long-term effects of the LINX device, potentially improving care for future patients. For you, the benefits are primarily from receiving the LINX treatment itself, which aims to improve your reflux symptoms. As with any medical procedure, there are potential risks associated with fitting the LINX device, and your doctor will discuss these with you before your procedure. The study itself involves time commitment for providing information but does not introduce new medical risks beyond the standard LINX procedure. You are free to withdraw from the study at any time without affecting your medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of South Alabama
Verified postcode
Mobile, United States
NW Allied Bariatric and Foregut Surgery
Verified postcode
Tucson, United States
Keck Hospital of USC
Verified postcode
Los Angeles, United States
Institute of Esophageal and Reflux Surgery
Verified postcode
Englewood, United States
University of Southern Florida (Tampa General Hospital)
Verified postcode
Tampa, United States
OSF Medical Group
Verified postcode
Peoria, United States
Saint Elizabeth Healthcare Edgewood
Verified postcode
Edgewood, United States
Sparrow Hospital / Sparrow Medical Group
Verified postcode
Lansing, United States
East Carolina University / Vidant Medical Center
Verified postcode
Greenville, United States
The Ohio State University
Verified postcode
Columbus, United States
Gen Surg Assoc / Fairfield Medical Center
Verified postcode
Lancaster, United States
Lehigh Valley Hospital - Cedar Crest
Verified postcode
Allentown, United States

Common questions

What is the LINX device?

It's a small ring of magnets placed around your food pipe to help stop acid reflux.

How long will I be followed in the study?

You will be followed for up to 10 years after you have the LINX device fitted.

Do I have to take extra medication for this study?

No, there are no extra medications involved for participating in this specific study.

What kind of information will I need to provide?

You'll be asked to fill in electronic questionnaires about your symptoms and how you're feeling.

Can I leave the study if I change my mind?

Yes, you can stop participating in the study at any time, and it won't affect your medical care.