On October 5, 2025, details emerged about a forthcoming clinical study focusing on patient preferences involving infusion systems for immunodeficiency treatment. Sponsored by KORU Medical Systems, Inc., the study is not yet recruiting but promises to assess how patients perceive mechanical infusion pumps for primary and secondary immunodeficiencies (PID and SID). Clinical, regulatory, and quality professionals should follow developments closely as they may have implications for device design and usability studies.
In this article:
- What changed?
- Why do patient preferences matter?
- What is the scope of the study?
- Frequently Asked Questions
- Conclusion
- Disclaimer
- Announcement link
What changed?
KORU Medical Systems has publicly announced its sponsorship of a new clinical trial intended to evaluate patient feedback on mechanical infusion pumps used in managing primary and secondary immunodeficiencies. Unlike many others, this study aims to directly involve end-users to identify potential barriers or areas of satisfaction while interacting with the device. While recruitment has not commenced, this signals a growing interest in prioritizing patient-centric approaches.
Why do patient preferences matter?
The use of mechanical infusion pumps plays an essential role in administering necessary treatments to individuals diagnosed with PID and SID. These devices often require frequent handling by patients, making usability and comfort critical factors for patient adherence and quality of life.
Clinical studies built around patient preferences could contribute to improving medical device performance, aligning more closely with intended use and optimizing device workflows for patients. Regulators and design teams alike should consider these insights pivotal when evaluating safety and performance criteria under MDR or FDA regulations.
What is the scope of the study?
The clinical study will investigate:
- The experiences and challenges patients face while using mechanical infusion pumps for PID and SID treatments.
- The comparative user-friendliness and perceived comfort of this technology as opposed to alternative systems.
- Data points that inform future enhancements in mechanical infusion pump designs, supporting human factors and usability engineering studies.
While the trial is still labeled as “not yet recruiting,” interested parties may want to stay informed about its progress. Early findings could help refine device manufacturing strategies and regulatory submissions. To access official updates, refer to the ClinicalTrials.gov listing.
What are Primary and Secondary Immunodeficiencies?
Primary immunodeficiencies refer to innate or hereditary conditions where the immune system does not function correctly, often requiring ongoing treatments. Secondary immunodeficiencies result from external factors such as infections or treatments like chemotherapy, similarly necessitating effective medical interventions. Devices that support the treatment of such conditions must balance complexity with ease of use.
Frequently Asked Questions
- Who is sponsoring the study?
KORU Medical Systems, Inc. - What device is being tested?
A mechanical infusion pump tailored to manage immunodeficiency conditions. - Can patients enroll now?
No, the study has not yet started recruiting participants. - Where can I find more details?
You can refer to ClinicalTrials.gov.
Conclusion
The upcoming study emphasizes the importance of patient usability feedback in improving medical device design and adherence. By focusing on mechanical infusion pumps for immunodeficiencies, KORU Medical Systems highlights a patient-centered approach that aligns with evidence-based practices and regulatory priorities. Stakeholders should monitor progress for actionable insights.
Disclaimer
This information is provided for professional reference purposes only. It does not constitute legal or clinical advice and should not replace consultation with medical experts or regulatory professionals.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07189013?term=medical+device