Active not recruitingNAINTERVENTIONAL

Alfapump® System in the Treatment of Refractory or Recurrent Ascites (POSEIDON Study)

The POSEIDON study is a research project for people in the UK who have ascites, which is a build-up of fluid in the tummy due to liver disease. This fluid often comes back despite standard treatments. The study is looking at how well a device called the Alfapump works. The pump is designed to automatically move this fluid from your tummy into your bloodstream, where it can be naturally removed by your body. Researchers want to see if the Alfapump can help manage ascites, improve quality of life, and reduce the need for frequent procedures to drain the fluid manually. Patients will also be followed for a long time to check the pump's safety and effectiveness.

At a glance

Status

Active not recruiting

Phase

Sponsor

Sequana Medical N.V.

Enrolment target

110

Start

16 Sep 2019

Estimated completion

30 Jun 2024

Ascites

What is this study about?

The POSEIDON study is looking at a new way to help people who have a condition called ascites. Ascites happens when too much fluid builds up in your tummy, usually because of serious liver disease. For some people, this fluid keeps coming back even with regular treatments and needs to be drained often, which can be uncomfortable and disruptive. This is called 'refractory' or 'recurrent' ascites.

This study is testing a special device called the Alfapump. Imagine a small pump that can be placed inside your body. Its job is to gently move the excess fluid from your tummy directly into your bloodstream. Once in the bloodstream, your body can then get rid of the fluid through your kidneys, much like how it handles other liquids you drink. The main goal of this study is to see if the Alfapump can effectively manage this fluid build-up, potentially reducing the need for frequent visits to the hospital for fluid drainage and improving how you feel day-to-day.

Researchers will follow people for a long time after the pump is put in, up to two years or even longer. This helps them understand how safe the pump is over time and how well it continues to work. The information gathered from this study will be used to help decide if the Alfapump should be made widely available as a treatment option for people with this type of ascites.

Key takeaways

The study is for people with stubborn fluid build-up (ascites) from liver disease.
It's testing a new internal pump called Alfapump to manage fluid.
Participation involves an initial observation phase, then possibly pump implantation.
You'll be followed for at least 2 years to check the pump's safety and how well it works.
The goal is to reduce the need for frequent fluid drainage procedures and improve quality of life.
The study aims to help decide if the Alfapump should be widely available.

Who may be eligible?

To join this study, you need to be over 18 years old and have a serious liver condition called cirrhosis, which has caused fluid to build up in your tummy (ascites). This fluid needs to be drained regularly, and you must have had at least two draining procedures in the month before you enrol. Also, other treatments like a TIPS procedure must not be suitable for you, or if you had one, it's no longer working.

There are also some important reasons why you might not be able to join. For example, if you have severe kidney problems, certain types of infections (like frequent urinary infections or particular tummy infections), or if you have certain types of liver cancer that are beyond a specific size or treatment plan. You also can't be pregnant or planning to get pregnant during the study period. Your doctor will carefully check all these points to see if the study is right for you.

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 over 18 years old?
Do you have liver cirrhosis with ascites that needs draining often?
Have you had at least two fluid drainage procedures in the last month?
Has your doctor said other treatments like TIPS are not suitable for you?
Do you not have severe kidney problems or certain infections?
Are you not pregnant and not planning to become pregnant during the study?

Answer every question to see your result.

What does participation involve?

If you join the main part of the study, you'll first have a 3-month observation period. During this time, you'll continue with your usual treatment for ascites, which is typically fluid drainage (paracentesis) when needed. Researchers will keep track of how often you need this and how much fluid is removed, as well as ask you questions about your quality of life. After these 3 months, if you're still suitable and have met certain criteria (like needing at least 5 fluid drainage procedures), you could have the Alfapump put in.

After the pump is implanted, you'll be followed closely for at least two years to check how well the pump is working and for any side effects. You'll have regular check-ups, and the pump is designed to be charged by you at home. If the pump is still working after two years, and you wish to, you can continue to be part of the study for even longer, with check-ups every 3 months. The total duration of your involvement could be several years, depending on how long the pump works or until the study concludes.

Potential risks and benefits

Participating in this study means you could potentially benefit from a new way to manage your ascites, possibly reducing the need for frequent fluid drainage and improving your quality of life. However, as with any medical procedure involving a device, there are potential risks, such as infection, problems with the pump itself, or issues related to the surgery to implant it. Your medical team will explain all known risks. Remember, taking part in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time without it affecting your usual medical care.

Locations (15)

Mayo Clinic (Arizona)
Verified postcode
Phoenix, United States
Cedars-Sinai Comprehensive Transplant Center
Verified postcode
Los Angeles, United States
University of Massachusetts Memorial Medical Center
Verified postcode
Worcester, United States
University of Minnesota
Verified postcode
Minneapolis, United States
Mayo Clinic
Verified postcode
Rochester, United States
Duke University
Verified postcode
Durham, United States
Hospital of the University of Pennsylvania
Verified postcode
Philadelphia, United States
Medical University of South Carolina
Verified postcode
Charleston, United States
Avera Medical Group
Verified postcode
Sioux Falls, United States
Methodist Dallas
Verified postcode
Dallas, United States
Baylor University Medical Center (Dallas)
Verified postcode
Dallas, United States
McGuire VA Medical Center
Verified postcode
Richmond, United States

Common questions

What is ascites?

Ascites is when too much fluid builds up in your tummy, usually because your liver isn't working properly.

What is the Alfapump?

The Alfapump is a small device that gets placed inside your body to automatically move extra fluid from your tummy into your bloodstream, where your body can get rid of it.

What does 'refractory or recurrent' mean for ascites?

It means your ascites keeps coming back or doesn't get better, even with regular treatment, and you need frequent fluid drainage.

How long will I be in the study?

If you get the pump, you'll be followed for at least two years. You might be able to continue for longer if you wish.

Will I still need fluid drainage if I have the pump?

The study aims to see if the pump can reduce or remove the need for fluid drainage, but this is what researchers are testing.