Assessing Patient Preference for Infusion Systems

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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

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Primary Immunodeficiencies (PID) Secondary Immunodeficiencies (SID)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experienced electronic pump users

Patients with earlier experience on electronic infusion pumps. They will use the mechanical infusion pump for three months' period.

Group Type EXPERIMENTAL

Mechanical infusion pump

Intervention Type DEVICE

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

Interventions

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Mechanical infusion pump

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

Intervention Type DEVICE

Other Intervention Names

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Freedom60 Infusion Pump

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No