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Clinical Trials in the UK / NCT07189013
Starting soon Not applicable

Assessing Patient Preference for Infusion Systems

NCT07189013 · tracked via the Priya Life Science UK tracker
Sponsor
KORU Medical Systems, Inc.
Phase
Not applicable
Started
2025-10-15
Last updated
2025-09-23

Condition(s) studied

Primary Immunodeficiencies (PID)Secondary Immunodeficiencies (SID)

Investigational drug(s) / intervention(s)

Mechanical infusion pump

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
King's College Hospital London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07189013 on ClinicalTrials.gov ↗ ← All trials in the UK