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NOT YET RECRUITING
NCT07189013
NA

Assessing Patient Preference for Infusion Systems

Sponsor: KORU Medical Systems, Inc.

View on ClinicalTrials.gov

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

DEVICE

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