Not yet recruitingNAINTERVENTIONAL

Assessment of a New Traction Device in Submucosal Dissection of Colorectal Lesions

This study looks into a new medical device, SureTrac, designed to make removing bowel growths easier and more effective. These growths can sometimes turn into bowel cancer. Currently, a method called submucosal dissection (SMD) is used for larger growths, but it can be tricky. SureTrac aims to provide a better way to hold and move the tissue during this procedure, potentially making it faster, safer, and more successful at removing the entire growth in one piece. This is important because removing the whole growth helps ensure thorough testing and reduces the chance of it coming back. The study wants to see how well SureTrac works in a hospital setting.

At a glance

Status

Not yet recruiting

Phase

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

Start

15 Dec 2025

Estimated completion

15 Jan 2027

Colorectal Cancer (MSI-H)

What is this study about?

Bowel cancer is a significant health concern, and it often starts from growths, similar to polyps, in the lining of the bowel. Doctors can usually remove these growths during a procedure called an endoscopy. For larger growths, a special technique called submucosal dissection (SMD) is often used because it allows doctors to take out the whole growth in one piece. This is important for making sure all the unhealthy cells are removed and can be properly checked in a lab, which helps prevent the cancer from returning.

However, SMD can be a challenging procedure. It's often more difficult than other methods, takes longer, and carries a slightly higher risk of complications, such as a small tear in the bowel. Because of these challenges, it’s usually only performed by highly experienced doctors in specialised centres. To make SMD easier and safer, doctors sometimes use tools that provide "traction," which means they gently pull the tissue to get a better view and make the removal process smoother.

This study is looking at a new traction device called SureTrac. It's designed to help doctors control the tissue better during SMD, potentially making the procedure less difficult, quicker, and safer. By improving the removal of these growths, the hope is to reduce the risk of them coming back and to ensure doctors can get a complete picture of the growth for diagnosis. This study will be one of the first to test how well SureTrac works in a real-world hospital setting.

Key takeaways

This study is testing a new device for removing bowel growths.
The device, SureTrac, aims to make a procedure called Submucosal Dissection (SMD) easier.
SMD is used for larger growths to remove them completely.
The study hopes to improve removal success and reduce complications.
It's an early-stage study to gather initial information on the device.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) and have a bowel growth larger than 2 centimetres that your doctor thinks can be safely removed using the SMD technique. You also need to be able to understand French and agree to take part by signing a consent form.

You would not be able to join if you are very unwell or have certain serious health conditions, such as problems with your blood clotting. People who have a history of certain bowel diseases like Crohn's or Ulcerative Colitis, or those who have had previous radiation treatment to their pelvic area, would also not be eligible. If you are pregnant or cannot attend follow-up appointments, you wouldn't be able to participate. The study also cannot include individuals who are under legal guardianship or are in prison.

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?
Do you have a bowel growth larger than 2cm?
Are you normally healthy enough for an endoscopy procedure?
Are you able to speak and understand French?
Do you have good general health without severe bleeding problems or certain bowel conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a medical procedure to remove a bowel growth using the new traction device. Doctors will closely monitor you during and after the procedure. You will likely have follow-up appointments to check on your recovery and to see how effective the removal was. The exact number of visits and the total length of your participation will be explained in detail by the study team, but typically, there will be a procedure and then some check-ups afterwards to make sure everything has healed well and the growth hasn't returned.

Potential risks and benefits

Taking part in this study might offer the benefit of having a new, potentially improved technique used to remove your bowel growth, which could lead to a more complete removal and better long-term outcomes. However, like any medical procedure, there are potential risks, such as a small chance of bleeding, infection, or a tear in the bowel lining. The study team will explain all known risks to you. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Hôpital Privé Jean Mermoz
Verified postcode
Lyon, France

Common questions

What is a bowel growth?

A bowel growth is a small lump or bump that forms on the inside lining of your bowel. Many are harmless, but some can turn into cancer over time.

What is Submucosal Dissection (SMD)?

SMD is a special procedure doctors use to remove larger bowel growths by carefully cutting them away from the bowel wall.

What is the SureTrac device?

SureTrac is a new tool designed to help doctors gently pull and hold the tissue during SMD, aiming to make the procedure easier and more precise.

Will I receive special treatment if I join?

You will receive the standard high quality of care, but the procedure will use this new medical device being tested in the study.

Is this new device safe?

The device has a safety mark (CE marked) which means it meets European safety standards. This study is designed to gather more information on its use.

How to find out more

Sarah LEBLANC, MD

sarahleblanc34@hotmail.com + 33 6 22 22 20 64 Official trial record

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