Assessing Patient Preference for Infusion Systems

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.

NCT Number	NCT07189013
Lead Sponsor	KORU Medical Systems, Inc.
Conditions	Primary Immunodeficiencies (PID), Secondary Immunodeficiencies (SID)
Enrollment	52 participants
Start Date	2025-10-15
Primary Completion	2026-03 (estimated)
Study Completion	2026-04 (estimated)
Updated on ClinicalTrials.gov	2025-09-23