Assessing Patient Preference for Infusion Systems

NCT07189013 | Not Yet Recruiting FDA Device

• 1 other identifier: KORU0001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Primary Immunodeficiencies (PID); Secondary Immunodeficiencies (SID)

Keywords

electronic infusion system; mechanical infusion system; immunodeficiency; subcutaneous immunoglobulin administration

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Three months

• Change in Handling Scores Between Electronic and Mechanical Infusion Pumps Measured on a 5-Point Likert Scale Over 3 Months

  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

  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

  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

  Three months

Study Arms (1)

Experienced electronic pump users

EXPERIMENTAL

Patients with earlier experience on electronic infusion pumps. They will use the mechanical infusion pump for three months' period.

Device: Mechanical infusion pump

Interventions

Mechanical infusion pump DEVICE

Patients with earlier experience on electronic infusion pumps will crossover to the mechanical infusion pump for three month's period

Also known as: Freedom60 Infusion Pump

Experienced electronic pump users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• KORU Medical Systems, Inc.: lead

Study Sites (1)

King's College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Anna Majapuro-Hirvonen

CONTACT

+358405697866; amajapuro@korumedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 23, 2025
• Study Start: October 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)