Assessing Patient Preference for Infusion Systems

KORU Medical Systems, Inc.

Status

Not yet enrolling

Conditions

Primary Immunodeficiencies (PID)

Secondary Immunodeficiencies (SID)

Treatments

Device: Mechanical infusion pump

Study type

Interventional

Funder types

Industry

Identifiers

NCT07189013

KORU0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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