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Assessing Patient Preference for Infusion Systems
Sponsor: KORU Medical Systems, Inc.
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.
Official title: Assessing Patient Preference for Infusion Systems (Electronic vs. Mechanical)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2025-10-15
Completion Date
2026-04
Last Updated
2025-09-23
Healthy Volunteers
No
Interventions
Mechanical infusion pump
Patients with earlier experience on electronic infusion pumps will crossover to the mechanical infusion pump for three month's period
Locations (1)
King's College Hospital
London, United Kingdom