RecruitingOBSERVATIONAL

A UK Registry for Metabolic and Bariatric Endoscopic Interventions

This is a UK study looking into new ways to help people with obesity and type 2 diabetes. Instead of traditional surgery, these new treatments use a special tube with a camera (an endoscope) inserted through the mouth to work on the stomach or bowel. Because these procedures are quite new, this study, called a registry, will gather important information from hospitals across the UK. Its main goal is to understand how safe and effective these endoscopic treatments are for weight loss and improving related health problems. The information collected will help doctors learn more, potentially making these treatments more widely available in the future for those who need them.

At a glance

Status

Recruiting

Sponsor

Cleveland Clinic London

Enrolment target

300

Start

01 Feb 2024

Estimated completion

01 Feb 2039

Obesity Diabetes Mellitus, Type 2

What is this study about?

Obesity is a major health concern in the UK, affecting more than a quarter of adults. It can lead to serious health issues like diabetes, heart disease, kidney problems, and even some cancers. People living with obesity often experience difficulties like breathlessness, back pain, problems with moving around, and can also suffer from poor mental health.

While diet and exercise are important for weight loss, it can be very hard to keep the weight off long-term for many people. For some, weight-loss surgery (bariatric surgery) is an option, which can be very effective. However, surgery comes with its own risks and not everyone is able or willing to have it. This has led to the development of newer, less invasive treatments that use an endoscope.

An endoscope is a thin, flexible tube with a camera on the end. It's gently guided through your mouth into your stomach and the first part of your small bowel. These special procedures can help with weight loss and improve health conditions linked to obesity. Because these treatments are quite new and only a few doctors in the UK currently perform them, this study wants to collect information from different hospitals across the country. By doing this, researchers hope to get a clearer picture of how well these procedures work and how safe they are in real life. This knowledge will help doctors learn more about using endoscopy to treat obesity and could lead to these treatments being more widely available in the future.

Key takeaways

This study collects information on new endoscopic (camera-based) weight loss treatments.
It helps doctors understand how safe and effective these procedures are in the UK.
It could lead to more availability of these treatments in the future.
You participate by allowing your medical information to be recorded, not by having extra procedures.
The goal is to improve care for people with obesity and type 2 diabetes.

Who may be eligible?

To be part of this study, you need to be an adult aged 18 or older who is already having one of these special endoscopic procedures for weight loss or related health problems in the UK. This includes both first-time procedures and those done to adjust previous treatments. You must also be able to understand the study and agree to take part by signing a consent form.

You would not be able to join if your procedure is happening outside of the UK, or if the specific procedure you're having isn't one that the study is currently tracking. Also, if you're unable to give your written consent to participate, you wouldn't be eligible.

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?
Are you currently having an endoscopic procedure for weight loss or related health issues in the UK?
Are you willing and able to sign a form agreeing to participate?
Is your procedure included in the study's list of approved treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't be undergoing any new or experimental procedure. You will already be having one of the approved endoscopic treatments. The study will simply collect information about you and your procedure, such as your age, gender, the type of procedure you have, and regular updates on your health and weight over time. This information will come from your medical records and follow-up appointments you would already be having with your doctor. This is an observational study, meaning it just collects information about your normal care, rather than asking you to do anything different than what your doctor recommends.

Potential risks and benefits

Taking part in this study does not involve any extra medical tests or changes to your treatment, as it simply collects information about the care you're already receiving. Therefore, there are no direct extra risks from being in the study itself. While there might not be a direct personal benefit to you, the information gathered from many people like you will help doctors understand these new treatments better. This could improve care for future patients and help make these procedures more widely available. You are free to withdraw your consent to participate at any time without affecting your medical care.

Locations (1)

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

Cleveland Clinic London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is an endoscope?

An endoscope is a thin, flexible tube with a camera on the end that doctors use to look inside your body without making a big cut.

Are these procedures new?

Yes, these treatments using an endoscope for weight loss are relatively new compared to traditional methods and bariatric surgery.

Will I get a new treatment if I join this study?

No, you will already be having one of these endoscopic procedures. The study just collects information about your treatment.

Who is running this study?

This is a UK-wide study collecting information from various hospitals and clinics across the country.

What will happen to my information?

Your anonymous health information will be collected to help doctors understand how safe and effective these treatments are, improving care for future patients.

How to find out more

Benjamin Norton, MD

cclendoscopyresearch@ccf.org +442034237500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.