Status:
NOT_YET_RECRUITING
Assessing Patient Preference for Infusion Systems
Lead Sponsor:
KORU Medical Systems, Inc.
Conditions:
Primary Immunodeficiencies (PID)
Secondary Immunodeficiencies (SID)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This crossover study evaluates patient experiences and preferences between mechanical and electrical infusion pumps for subcutaneous immunoglobulin (SCIg) therapy. The Freedom Integrated Infusion Syst...
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07189013
Start Date
October 15 2025
End Date
April 1 2026
Last Update
September 23 2025
Active Locations (1)
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1
King's College Hospital
London, United Kingdom