NCT07189013

Assessing Patient Preference for Infusion Systems

Assessing Patient Preference for Infusion Systems (Electronic vs. Mechanical)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: KORU Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Primary Immunodeficiencies (PID)
• Secondary Immunodeficiencies (SID)

Interventions

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

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study