RecruitingOBSERVATIONAL

Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss

This study, called "Five Plus Year Efficacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained Weight Loss," is looking into the long-term effects of a weight loss procedure called Endoscopic Sleeve Gastroplasty (ESG). Specifically, it aims to see how well people have managed to lose weight and keep it off five years or more after having the ESG procedure. Researchers will be looking back at past information from patients who had the procedure, and some patients might also be asked to come in for one final check-up. The main goal is to understand the full weight loss journey and the lasting impact of ESG on people living with obesity and related health conditions.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

100

Start

31 Mar 2026

Estimated completion

01 Dec 2026

Obesity and Obesity-related Medical Conditions Weight Loss

What is this study about?

This study is particularly interested in a weight loss procedure called Endoscopic Sleeve Gastroplasty, or ESG for short. This procedure involves using a special tool through the mouth to stitch and reshape the stomach, making it smaller. The main idea is that with a smaller stomach, you feel full sooner and eat less, which helps with weight loss. What makes this study stand out is its focus on the `long term` – specifically, how people have fared five years or even longer after having the ESG procedure. Many studies look at short-term results, but understanding the five-year-plus journey is really important for knowing how effective ESG truly is over time.

The researchers want to gather information from people who had ESG a good while ago to see if they’ve kept the weight off and how their health has changed. This kind of research helps doctors and patients understand what to expect from ESG in the years following the procedure. It’s about building a clearer picture of sustained weight loss and overall health improvements related to this treatment for obesity.

By gathering this long-term evidence, the study aims to provide valuable insights into the full weight loss journey for patients who undergo ESG. This information can then help healthcare professionals better advise individuals considering ESG, giving them a more complete understanding of the potential long-term benefits.

Key takeaways

This study evaluates weight loss results five or more years after ESG.
It helps understand the long-term effectiveness of the ESG procedure.
Participation mainly involves reviewing your medical records and possibly one follow-up visit.
There are no new treatments or medications involved.
Your contribution will help future patients considering ESG.

Who may be eligible?

To be part of this study, you would have had the ESG procedure, using a specific stitching system, when you were at least 18 years old. At the time of your ESG procedure, your body mass index (BMI) — a measure of weight in relation to height — would have been between 30 and 50. This range typically identifies individuals who are considered obese.

It's also important that you completed your one-year check-up after the ESG procedure for your weight management. You also need to have had at least one further annual check-up at the hospital or clinic where you had your procedure, sometime between two and four years afterwards. Finally, you would be willing to come in for one last check-up for the study (if you haven't recently had your five-year or later appointment) and be able to understand and sign a consent form.

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.

I had my ESG procedure when I was 18 years old or older.
At the time of my ESG, my BMI was between 30 and 50.
I completed my one-year follow-up appointment after my ESG.
I had at least one annual check-up between two and four years after my ESG.
I'm willing to come in for one final check-up for the study (if needed).

Answer every question to see your result.

What does participation involve?

If you join this study, much of the information the researchers need will be taken from your existing medical records from your past check-ups. This is called ‘retrospective data collection’, meaning they are looking back at information already collected about your health and weight loss journey.

In addition to looking at your past records, you would also be asked to come in for one visit. This visit would be your 5-year or later follow-up appointment, depending on when you had your ESG procedure. During this visit, routine measurements and discussions about your health and weight management would take place, just like a regular follow-up appointment. There are no new medications or special treatments involved in this study; it's purely about observing and collecting information about your weight loss journey after ESG.

Potential risks and benefits

As this study mainly involves looking at your past medical records and possibly one standard follow-up visit, there are very few direct risks. The main benefit is that your information will help us understand the long-term success of the ESG procedure for many others in the future. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (8)

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

Endeavor Health Evanston Hospital
Verified postcode
Evanston, United States· Recruiting
The University of Texas Health Science Center at Houston
Verified postcode
Bellaire, United States· Recruiting
The BMI Clinic
Verified postcode
Double Bay, Australia· Not yet recruiting
CHU de Strasbourg, IHU-Strasbourg
Verified postcode
Strasbourg, France· Not yet recruiting
Mohak hi-tech Specialty Hospital
Verified postcode
Indore, India· Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Verified postcode
Rome, Italy· Not yet recruiting
New You Medical Center
Verified postcode
Riyadh, Saudi Arabia· Not yet recruiting
Spire Southampton
Verified postcode
Southampton, United Kingdom· Not yet recruiting

Common questions

What is Endoscopic Sleeve Gastroplasty (ESG) exactly?

ESG is a way to make your stomach smaller using stitches inserted through your mouth, without needing surgery involving cuts. It helps you feel full faster and eat less.

Why is this study important?

This study is important because it looks at how well ESG works over a long time (five years or more). This helps us understand if the weight loss is lasting and how people's health changes.

Do I have to take any new medicines if I join?

No, this study doesn't involve any new medicines or treatments. It's about collecting information on how you've been doing since your ESG procedure.

What if I decide I don't want to be in the study anymore?

You can leave the study at any time, for any reason. It won't affect your medical care in any way.

How will my personal information be kept safe?

The researchers will protect your personal information and use it only for this study, following strict rules to keep it confidential.

How to find out more

Maxime Oriol

maxime.oriol@bsci.com 978-790-8009 Official trial record

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