Not yet recruitingNAINTERVENTIONAL

Assessing Patient Preference for Infusion Systems

This study is for adults in the UK who have conditions that weaken their immune system, like primary or secondary immunodeficiency, and are treated with special medicines given under the skin. We're comparing two kinds of small pumps used to give these medicines: existing electronic pumps and a newer, simpler mechanical pump that doesn't need batteries or electricity. The aim is to see which pump people find easier to use, more comfortable, and generally prefer. If you’ve been using an electronic pump for at least three months, you could be asked to try the mechanical one and tell us what you think. Your feedback will help patients and doctors choose the best pumps for their treatment.

At a glance

Status

Not yet recruiting

Phase

Sponsor

KORU Medical Systems, Inc.

Enrolment target

Start

15 Oct 2025

Estimated completion

01 Apr 2026

Primary Immunodeficiencies (PID)Secondary Immunodeficiencies (SID)

What is this study about?

Imagine you have a condition where your immune system isn't working as well as it should. To help, you might receive a special medicine called immunoglobulin, often given through a small pump that delivers it just under your skin. This study wants to understand your experience with these pumps.

We're comparing two types: the electronic pumps many people currently use, and a newer, mechanical pump called the Freedom Integrated Infusion System. The Freedom pumps are designed to be quite simple – they don't need batteries or electricity and are portable. We want to know if these simpler pumps are better for you in terms of how easy they are to learn, how comfortable they are to use, and your overall satisfaction compared to the electronic pumps.

About 78 adults will be taking part in this study. If you've been using an electronic pump for at least three months, you'll be asked to try the mechanical pump. You'll fill out some questionnaires about both your current pump and the new mechanical one. Your honest feedback is really important as it will help healthcare professionals and other patients make informed decisions about which infusion pump might be best for their treatment.

Key takeaways

Compares existing electronic pumps with new mechanical pumps.
Aims to find out which pump patients prefer for comfort and ease of use.
For adults with immune system conditions who use infusion pumps.
Involves trying a new pump and completing questionnaires.
May help improve future pump choices for patients.

Who may be eligible?

This study is looking for adults who are currently receiving a specific treatment called immunoglobulin replacement therapy because they have a primary or secondary immune system problem, or a nerve condition called CIDP. It's important that you or your carer are happy and able to understand and sign a consent form to take part.

Crucially, you should already be familiar with using an electronic pump for your treatment and have been using one for at least three months. If you've been on this therapy for less than three months, or if you're under 18 years old, this study isn't suitable for you. Also, if you're already involved in another clinical study right now, you won't be able to join this one until that study finishes.

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 primary or secondary immune system problem or a related nerve condition?
Are you currently receiving immunoglobulin therapy?
Have you been using an electronic infusion pump for at least 3 months?
Are you able and willing to fill out questionnaires about your experience?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to share your experiences by filling out a couple of questionnaires. First, you'll complete one about your current electronic infusion pump, describing how you find using it. Then, you'll try out one of the mechanical Freedom pumps for a period. After using the mechanical pump, you'll fill out a second questionnaire to tell us about that experience. The questionnaires will cover things like how easy the pumps are to use, how comfortable they are during infusion, and your overall satisfaction. There are no specific visits mentioned beyond completing these questionnaires. There's no new medication involved, just trying a different device to give your existing medicine. The total duration of your involvement isn't specified but would involve the time needed to try the new pump and complete both sets of questionnaires.

Potential risks and benefits

Taking part in this study may offer the benefit of trying a different type of infusion pump that you might find more comfortable or easier to use, which could improve your treatment experience. There are minimal risks involved, as you would continue to receive your usual medication. The main 'risk' might be the time taken to complete the questionnaires and learn a new device. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

King's College Hospital
Verified postcode
London, United Kingdom

Common questions

What is an 'immunodeficiency'?

It's a condition where your body's immune system, which fights off infections, doesn't work as well as it should.

What kind of pumps are being compared?

We're comparing the electronic pumps many people already use with new mechanical pumps that don't need batteries or electricity.

Do I have to change my medication?

No, you don't. You will continue to take your regular immunoglobulin medicine, just with a different pump for the study period.

Who can take part in this study?

Adults (18 or over) with an immune system problem who have been using an electronic infusion pump for at least 3 months for their treatment.

What will happen if I join the study?

You'll fill out questionnaires about your current pump, then try a mechanical pump, and fill out another questionnaire about that experience.

How to find out more

Anna Majapuro-Hirvonen

amajapuro@korumedical.com +358405697866 Official trial record

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