RecruitingOBSERVATIONAL

Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing

This study, called a Post-Market Clinical Follow-up (PMCF) study, is observing how a medical device named Suprasorb® CNPendo works in real-world settings. It's designed for people who have injuries or wounds in their food pipe (oesophagus) or back passage (rectum), such as tears or problems after surgery. Healthcare professionals will be using the device as they normally would, following the instructions it comes with. The study will simply collect information on how patients are doing while using this treatment, without changing any of their usual care. The aim is to understand more about how effectively the device helps these sensitive areas heal in everyday medical practice.

At a glance

Status

Recruiting

Sponsor

Lohmann & Rauscher

Enrolment target

110

Start

03 Jun 2024

Estimated completion

01 Sep 2027

Esophagus Injury Rectal Lesion

What is this study about?

This study is looking at how a special medical device, called Suprasorb® CNPendo, helps people who have injuries in their food pipe (oesophagus) or back passage (rectum). These injuries can be things like tears or problems that happen after surgery. The food pipe carries food from your mouth to your stomach, and the back passage is the end part of your bowel.

Doctors are already using this device to help these types of injuries heal. This study isn't testing a new treatment or asking you to do anything different from your usual care. Instead, it's carefully watching patients who are already being treated with Suprasorb® CNPendo to see how well it works in real-life hospital settings. The term 'negative pressure therapy' means it gently draws fluids away from the wound to help it close and heal better.

The main goal is to gather more information about the device's effectiveness and how it helps patients recover. By observing how patients are treated and how their wounds heal, doctors and scientists can learn more about the best ways to use this device to support healing in these important parts of the body.

Key takeaways

This study observes how a device called Suprasorb® CNPendo helps heal injuries in the food pipe or back passage.
It's for patients already receiving this treatment as part of their routine care.
No new treatments or procedures are involved; it simply collects information from your regular medical care.
Your privacy is protected, and your health information will be used to improve understanding of the device.
Participating helps contribute to better future care for people with similar injuries.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. You must have a recent injury or wound in your food pipe (oesophagus) or back passage (rectum). This could include tears or problems after an operation, and your doctors must believe that treatment with the Suprasorb® CNPendo device is the right choice for you.

There are also some reasons why you might not be able to join. For example, if you have certain blood clotting problems that increase your risk of bleeding, or if your injury affects your breathing tubes (like your windpipe or lungs), you wouldn't be able to take part. Also, if you're allergic to any part of the Suprasorb® CNPendo device, or if your doctor feels the device can't be used exactly as it's meant to be, then you wouldn't be suitable for the study.

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 recent injury or wound in your food pipe or back passage?
Has your doctor decided that the Suprasorb® CNPendo device is the right treatment for your injury?
Do you not have any serious blood clotting problems?
Is your injury only in your food pipe or back passage, and not also involving your breathing tubes (like your windpipe)?
Are you not allergic to any parts of the Suprasorb® CNPendo device?

Answer every question to see your result.

What does participation involve?

If you join this study, your medical care for your food pipe or back passage injury will continue exactly as your doctors normally plan it. This study won't change your treatments, appointments, or medications in any way. You will receive the Suprasorb® CNPendo device as part of your standard care, and the hospital will simply collect information about how you're doing and how your injury is healing. This means there are no extra study visits, tests, or procedures you need to attend beyond your usual medical appointments. The information collected will be based on your routine medical records, and your participation will last for as long as you are receiving care for your injury that involves the device.

Potential risks and benefits

Since this study only observes medical care you are already receiving, there are no additional risks directly from participating in the study itself. Any risks would be related to the medical treatment you are getting for your condition, which your doctor will discuss with you. The potential benefit is that by sharing your routine health information, you contribute to a better understanding of how the Suprasorb® CNPendo device helps patients heal. This knowledge can improve future care for others. You are free to withdraw your consent for your data to be used at any time, without affecting your medical treatment.

Locations (7)

Uniklinik Berlin Charite
Verified postcode
Berlin, Germany· Recruiting
Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University
Verified postcode
Mannheim, Germany· Recruiting
Clinic for general, visceral and transplant surgery at the University of Munich
Verified postcode
Munich, Germany· Recruiting
Uniklinik MRI
Verified postcode
Munich, Germany· Not yet recruiting
Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Verified postcode
Münster, Germany· Recruiting
Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie
Verified postcode
Rheine, Germany· Recruiting
Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is the Suprasorb® CNPendo device?

It's a medical device used to help heal injuries in your food pipe (oesophagus) or back passage (rectum) by gently drawing fluids away from the wound.

Will I receive a new or different treatment if I join this study?

No, you will receive the same care and treatment as you normally would. This study only observes patients already using the device.

How to find out more

Daria Trofimenko, MD

daria.trofimenko@de.lrmed.com +49 (0)2631- 99 6385 Official trial record

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