Primary Immunodeficiencies (PID)NCT07189013
Assessing Patient Preference for Infusion Systems
A study testing Mechanical infusion pump in people with Primary Immunodeficiencies (PID) and Secondary Immunodeficiencies (SID), run by KORU Medical Systems, Inc. at 1 site in United Kingdom.
Trial summary
This crossover study evaluates patient experiences and preferences between mechanical and electrical infusion pumps for subcutaneous immunoglobulin (SCIg) therapy. The Freedom Integrated Infusion System (FREEDOM60 and FreedomEdge) are mechanical, portable pumps that require no batteries or electricity and use… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immunodeficiencies (PID), Secondary Immunodeficiencies (SID)
- What is being tested?
- Mechanical infusion pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has primary or secondary immunodeficiency or chronic inflammatory demyelinating polyneuropathy and is undergoing IgRT.
- The subject or caregiver is willing and able to provide informed consent.
- The subject has experience using electronic SCIG infusion system (3 months and above).
Who cannot join
- The subject is participating in another clinical study prior to this study completion.
- The subject has been on IgRT for less than 3 months.
- The subject is less than 18 years old and/or has a legal representative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
King's College Hospital
London
Anna Majapuro-Hirvonen, +358405697866, amajapuro@korumedical.com
About this study
Official title: Assessing Patient Preference for Infusion Systems (Electronic vs. Mechanical)
This crossover study evaluates patient experiences and preferences between mechanical and electrical infusion pumps for subcutaneous immunoglobulin (SCIg) therapy. The Freedom Integrated Infusion System (FREEDOM60 and FreedomEdge) are mechanical, portable pumps that require no batteries or electricity and use Precision Flow Rate Tubing™ to control infusion speed. These devices are approved for use in the EU (CE650520).
Approximately 78 adult patients with primary or secondary immunodeficiency will participate. Participants will complete questionnaires assessing ease of training, ease of use, infusion comfort, and overall satisfaction. Patients experienced with electronic pumps will complete two questionnaires: one reflecting their current pump experience and one after trying the mechanical pump.
The primary goal is to determine whether mechanical pumps provide greater patient satisfaction than electrical pumps. Results will inform patient and healthcare professional decision-making regarding pump selection.
Read the detailed description
Study Objective:
To assess patient preference, ease of training, ease of use, and satisfaction with mechanical versus electrical infusion pump systems.
Subject Population:
Adults with primary or secondary immunodeficiency receiving subcutaneous immunoglobulin therapy, including patients experienced with electronic infusion pumps.
Hypothesis:
Mechanical infusion pumps will provide greater patient satisfaction compared with electrical infusion pumps during SCIg treatment.
Study Assessments / Evaluations:
Experienced electronic pump users will complete two questionnaires: one reflecting their current pump experience and one after trying a mechanical pump. Comparisons will evaluate preference, satisfaction, ease of use, training, infusion comfort, handling, instructions, troubleshooting, and safety.
Number of Subjects:
Approximately 78 patients, completing 130 questionnaires in total.
- Being tested
- Mechanical infusion pump
- Keywords
- electronic infusion system, mechanical infusion system, immunodeficiency, subcutaneous immunoglobulin administration
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical infusion pumpDevice
Also called Freedom60 Infusion Pump
Patients with earlier experience on electronic infusion pumps will crossover to the mechanical infusion pump for three month's period
| Study group | Role | What they receive |
|---|---|---|
| Experienced electronic pump users | Experimental | Patients with earlier experience on electronic infusion pumps. They will use the mechanical infusion pump for three months' period. Receives: Device: Mechanical infusion pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Satisfaction Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Participants will first provide a retrospective evaluation of their prior experience with an electronic infusion pump using a 5-point Likert scale (where 1 = worst outcome and 5 = best outcome). They will then crossover to a mechanical infusion pump for 3 months, after which satisfaction will again be assessed on the same scale. The primary outcome is the difference in satisfaction scores between electronic and mechanical pump use.
Measured: Three months
Secondary outcomes (5)
Change in Ease of Use Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Participants will first provide a retrospective evaluation of the ease of use of an electronic infusion pump using a 5-point Likert scale (1 = very difficult to use; 5 = very easy to use). They will then crossover to a mechanical infusion pump for 3 months, after which ease of use will again be assessed on the same scale. The secondary outcome is the difference in ease-of-use scores between electronic and mechanical pump use.
Measured: Three months
Change in Handling Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Participants will first provide a retrospective evaluation of the handling of an electronic infusion pump using a 5-point Likert scale (1 = very difficult to handle; 5 = very easy to handle). They will then crossover to a mechanical infusion pump for 3 months, after which handling will again be assessed on the same scale. The secondary outcome is the difference in handling scores between electronic and mechanical pump use.
Measured: Three months
Change in Scores for Clarity of Instructions of Use Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Participants will first provide a retrospective evaluation of the clarity of instructions of use for an electronic infusion pump using a 5-point Likert scale (1 = very unclear instructions; 5 = very clear instructions). They will then crossover to a mechanical infusion pump for 3 months, after which clarity of instructions of use will again be assessed on the same scale. The secondary outcome is the difference in clarity-of-instructions scores between electronic and mechanical pump use.
Measured: Three months
Change in Scores for Ability for Troubleshooting Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Participants will first provide a retrospective evaluation of the ability for troubleshooting any issues that may arise during the infusion for an electronic infusion pump using a 5-point Likert scale (1 = not at all confident; 5 = very confident). They will then crossover to a mechanical infusion pump for 3 months, after which clarity of instructions of use will again be assessed on the same scale. The secondary outcome is the difference in ability for troubleshooting scores between electronic and mechanical pump use.
Measured: Three months
Change in Scores for Pain and Discomfort Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Participants will first provide a retrospective evaluation of the clarity of instructions of use for an electronic infusion pump using a 5-point Likert scale (1 = extreme pain and discomfort; 5 = no pain and discomfort). They will then crossover to a mechanical infusion pump for 3 months, after which clarity of instructions of use will again be assessed on the same scale. The secondary outcome is the difference in clarity-of-instructions scores between electronic and mechanical pump use.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiencies (PID)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KORU Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189013
- Sponsor's protocol ID
- KORU0001
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Preference for Infusion Systems (Electronic vs. Mechanical)
- ClinicalTrials.gov ID
- NCT07189013
- Acronym / sponsor ID
- KORU0001
- Keywords
- electronic infusion system, mechanical infusion system, immunodeficiency, subcutaneous immunoglobulin administration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- KORU Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This crossover study evaluates patient experiences and preferences between mechanical and electrical infusion pumps for subcutaneous immunoglobulin (SCIg) therapy. The Freedom Integrated Infusion System (FREEDOM60 and FreedomEdge) are mechanical, portable pumps that require no batteries or electricity and use Precision Flow Rate Tubing™ to control infusion speed. These devices are approved for use in the EU (CE650520).
Approximately 78 adult patients with primary or secondary immunodeficiency will participate. Participants will complete questionnaires assessing ease of training, ease of use, infusion comfort, and overall satisfaction. Patients experienced with electronic pumps will complete two questionnaires: one reflecting their current pump experience and one after trying the mechanical pump.
The primary goal is to determine whether mechanical pumps provide greater patient satisfaction than electrical pumps. Results will inform patient and healthcare professional decision-making regarding pump selection.
Detailed description
Study Objective:
To assess patient preference, ease of training, ease of use, and satisfaction with mechanical versus electrical infusion pump systems.
Subject Population:
Adults with primary or secondary immunodeficiency receiving subcutaneous immunoglobulin therapy, including patients experienced with electronic infusion pumps.
Hypothesis:
Mechanical infusion pumps will provide greater patient satisfaction compared with electrical infusion pumps during SCIg treatment.
Study Assessments / Evaluations:
Experienced electronic pump users will complete two questionnaires: one reflecting their current pump experience and one after trying a mechanical pump. Comparisons will evaluate preference, satisfaction, ease of use, training, infusion comfort, handling, instructions, troubleshooting, and safety.
Number of Subjects:
Approximately 78 patients, completing 130 questionnaires in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experienced electronic pump users | Experimental | Device: Mechanical infusion pumpPatients with earlier experience on electronic infusion pumps. They will use the mechanical infusion pump for three months' period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject has primary or secondary immunodeficiency or chronic inflammatory demyelinating polyneuropathy and is undergoing IgRT.
- The subject or caregiver is willing and able to provide informed consent.
- The subject has experience using electronic SCIG infusion system (3 months and above).
Key exclusion criteria (3 listed)
- The subject is participating in another clinical study prior to this study completion.
- The subject has been on IgRT for less than 3 months.
- The subject is less than 18 years old and/or has a legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical infusion pumpAlso: Freedom60 Infusion PumpPatients with earlier experience on electronic infusion pumps will crossover to the mechanical infusion pump for three month's period | Device | Experienced electronic pump users |
Primary outcome
Change in Patient Satisfaction Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Time frame: Three months
Participants will first provide a retrospective evaluation of their prior experience with an electronic infusion pump using a 5-point Likert scale (where 1 = worst outcome and 5 = best outcome). They will then crossover to a mechanical infusion pump for 3 months, after which satisfaction will again be assessed on the same scale. The primary outcome is the difference in satisfaction scores between electronic and mechanical pump use.
5 secondary outcomes
Change in Ease of Use Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Time frame: Three months
Change in Handling Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Time frame: Three months
Change in Scores for Clarity of Instructions of Use Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Time frame: Three months
Change in Scores for Ability for Troubleshooting Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Time frame: Three months
Change in Scores for Pain and Discomfort Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical infusion pump in people with Primary Immunodeficiencies (PID) and Secondary Immunodeficiencies (SID), run by KORU Medical Systems, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Majapuro-Hirvonen (+358405697866, amajapuro@korumedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Satisfaction Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.