Assessing Patient Preference for Infusion Systems
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKORU Medical Systems, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mechanical infusion pump
Treatment groups
52 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov