Active not recruitingOBSERVATIONAL

International Alfapump Cohort Study

This study, called the International Alfapump Cohort Study, is designed to keep an eye on people who have been given a medical device called an alfapump. This pump is used for serious health problems like liver cirrhosis (a type of severe liver damage) and malignant ascites (fluid build-up caused by cancer). The alfapump is a new product from a company called Sequana Medical AG. The main goal is to understand how the alfapump works in real-life situations once it's been implanted. Researchers are looking at all patients who have received an alfapump in the way it's meant to be used, unless they are already part of another study testing this specific pump. It includes people of all ages, both men and women, as long as they are over 18 and not pregnant.

At a glance

Status

Active not recruiting

Sponsor

Sequana Medical N.V.

Enrolment target

400

Start

14 Aug 2018

Estimated completion

31 Dec 2030

Liver Cirrhoses Malignant Ascites

What is this study about?

This study is called the International Alfapump Cohort Study. It's not a typical trial where a new treatment is being tested against an old one. Instead, it's more like a registry or a monitoring program. Imagine it like a follow-up club for people who have received a specific medical device called an alfapump.

The alfapump is a special pump designed to help people with very serious health conditions like liver cirrhosis. Liver cirrhosis means the liver is severely damaged and scarred, which can lead to fluid building up in the tummy, a condition called ascites. This fluid build-up can also happen in people with certain types of cancer, which is known as malignant ascites. The alfapump helps to remove this fluid.

Since the alfapump is a new product, doctors and the company that makes it want to see how it works for people in their daily lives, outside of strict research settings. By collecting information from many people, they can get a better understanding of its overall performance and how it helps patients.

Key takeaways

It's about observing how the alfapump works in real life.
Participation is for people who already have an alfapump.
No extra appointments or treatments are involved.
Helps doctors learn more about the alfapump's long-term effects.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you must have received an alfapump. This study is generally open to anyone who has had an alfapump implanted as part of their standard medical care, as long as they are not currently involved in another research study that is also looking at the alfapump. It’s important that the pump was put in for the reasons it's designed to be used.

However, there are a few reasons why you wouldn't be able to join. You need to be at least 18 years old. Also, if you are pregnant, or if you can't use the 'Smart Charger' (a device needed to recharge the alfapump), then you wouldn't be able to take part. These rules are in place to make sure the study gathers useful information safely.

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 have an alfapump implanted.
I am not currently in another study looking at the alfapump.
I am 18 years old or older.
I am not pregnant.
I can operate the alfapump's Smart Charger.

Answer every question to see your result.

What does participation involve?

If you join this study, it mainly involves your medical information being collected and followed over time. Since the alfapump is already implanted as part of your treatment, you won't be given any new medications specifically for the study. There are no extra doctor's visits or special tests just for the study; instead, information will be gathered from your regular check-ups and medical records related to your alfapump and your condition.

The study aims to follow people long-term to see how the alfapump works over time. There isn't a set end date for your individual participation; you will be followed for as long as needed to understand the pump's performance in a real-world setting. You will continue to have your standard medical care and follow-up for your condition and the alfapump, and the study will use information from these appointments.

Potential risks and benefits

The main benefit of taking part in this study is that it helps doctors and researchers learn more about how the alfapump works for people like you. This information can improve future care for others with similar conditions. Since the alfapump is already part of your treatment, there are no additional medical risks from simply being included in this observational study. However, you should always discuss any concerns about the alfapump itself with your doctor. You are always free to decide to leave the study at any time without it affecting your medical care.

Locations (2)

Universitätsklinikum Leipzig
Verified postcode
Leipzig, Germany
Inselspital
Verified postcode
Bern, Switzerland

Common questions

What is an alfapump?

The alfapump is a special medical device that helps people with serious liver problems or certain cancers that cause fluid to build up in their tummy.

Is this a new treatment being tested?

No, this study isn't testing a new treatment. It's following people who have already had an alfapump implanted to see how it works in everyday life.

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

No, you don't need extra visits or tests for this study. Information will be collected from your existing medical records and routine check-ups.

Who is running this study?

This study is being run internationally, and information is collected from patients who have received an alfapump made by a company called Sequana Medical AG.

Can I stop being part of the study once I've joined?

Yes, you can choose to stop your participation at any time without it affecting your medical care or treatment.