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Endoscopic Gastric Tubulization

This study is about a procedure called endoscopic gastric tubulization, which is a keyhole surgery for adults dealing with very severe obesity. It's done using a special stitching device called Overstitch. Doctors in Strasbourg, France, have been offering this procedure since 2016. The main goal of the study is to gather information from patients who have had this procedure. Researchers want to see how much weight patients lose, if their quality of life improves, and if other health problems linked to obesity get better. They also want to understand if the procedure works well for everyone and how long its effects last. This information is collected during regular check-up appointments for up to two years after the procedure.

At a glance

Status
Recruiting
Sponsor
IHU Strasbourg
Enrolment target
300
Start
08 Jun 2018
Estimated completion
01 Jun 2028

What is this study about?

This study is looking at a treatment called endoscopic gastric tubulization for adults who are very severely overweight (this is sometimes called 'morbid obesity'). This procedure helps people lose weight by making their stomach smaller, similar to other stomach-reducing surgeries. The key difference is that this method is much less invasive, meaning it doesn't involve large cuts or major surgery on your body. It's done using a special flexible tube that goes down your throat, with a small camera and a stitching device attached.

The idea behind making the stomach smaller is to help you feel full after eating less food, leading to weight loss. While traditional weight-loss surgeries are very effective, they can sometimes have serious risks. This endoscopic approach aims to achieve similar good results – like losing weight, feeling better, and improving health problems linked to obesity – but with fewer risks and a quicker recovery. In fact, it's often done as a day procedure, meaning you wouldn't need to stay in hospital overnight.

Another important point about this specific procedure is that it can potentially be reversed if needed, or if you decide to have a different procedure later on. The study is collecting information from patients who undergo this procedure to understand how well it works in the long term, how satisfied patients are, and if the benefits last for at least two years. This helps doctors learn more about who benefits most and how to best use this technique.

Key takeaways

  • The study looks at a keyhole stomach-shrinking procedure for severe obesity.
  • It uses a special stitching device already in regular use.
  • Researchers will track weight loss, health improvements, and quality of life for 2 years.
  • Participation involves sharing routine medical data; no extra appointments are needed.
  • The procedure aims for similar results to surgery but with fewer risks and quicker recovery.

Who may be eligible?

To be considered for this study, you would need to be an adult between 18 and 65 years old. The main requirement for joining is that you are scheduled to have the endoscopic gastric tubulization procedure at the Nouvel Hôpital Civil hospital in Strasbourg, France.

This study is open to both men and women who meet these age and treatment location criteria. It's important to remember that this study isn't about trying a new, experimental treatment; it's about gathering information on a procedure that is already part of standard care at this specific hospital.

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.

  1. Are you an adult aged between 18 and 65 years?
  2. Are you scheduled to have endoscopic gastric tubulization?
  3. Will you be having your procedure at the Nouvel Hôpital Civil in Strasbourg, France?
  4. Do you want to help doctors learn more about this procedure?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you wouldn't be asked to do anything extra or different from what a patient normally does when having this procedure. You would have your endoscopic gastric tubulization procedure as planned. The medical team would then simply collect information from your regular check-up appointments, starting from your last visit before the procedure and continuing for up to two years afterwards. This information helps them understand the procedure's effects on your weight, health, and how you feel generally. There are no special medications or additional visits required just for the study; it all happens as part of your usual care.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical knowledge. By allowing your routine health information to be collected, you help doctors understand how well this procedure works in the long run for people like you, which can improve care for future patients. As for risks, since this study only involves collecting data from your routine medical care after the procedure, there are no additional risks associated with the study itself beyond the usual risks of the endoscopic gastric tubulization procedure, which your doctors will discuss with you. You always have the right to withdraw from the study at any time, meaning you can ask for your information not to be used, without affecting your medical care.

Locations (1)

  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
    Verified postcode
    Strasbourg, France· Recruiting

Common questions

What is endoscopic gastric tubulization?

It's a keyhole procedure to make your stomach smaller using an internal stitching device, without needing major surgery.

Why are doctors doing this study?

They want to understand how well the procedure helps with weight loss, improves health, and how long these benefits last over two years.

Do I have to do anything extra if I join the study?

No, you just continue with your normal doctor appointments after the procedure. The study collects information from these routine visits.

Where is this procedure and study taking place?

It's at the Nouvel Hôpital Civil in Strasbourg, France.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any point without it affecting your medical care.

How to find out more

Silvana Perretta, MD, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Endoscopic Gastric Tubulization…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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