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Evaluating DFPP for Microplastic Reduction
Sponsor: Efforia, Inc
Summary
This prospective, non-interventional, within-subject paired biomarker study will evaluate whether circulating microplastic and nanoplastic-associated particle concentrations in peripheral blood change after clinically prescribed double-filtration plasmapheresis (DFPP). Twenty adult volunteers already undergoing DFPP independent of research participation will provide paired pre- and post-treatment blood samples. The primary endpoint is within-participant change in microplastic and nanoplastic-associated particle concentration measured by nano-flow cytometry with Nile Red staining. An exploratory subset of five participants will undergo Py-GC-MS analysis of paired blood samples and DFPP eluate to evaluate polymer-specific mass changes and the presence of plastic polymers in eluate. DFPP treatment decisions and procedural parameters are determined solely by the treating physician as part of routine care.
Official title: Removal of Microplastics and Nanoplastics From Human Peripheral Blood Via Double-Filtration Plasmapheresis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2026-06-12
Completion Date
2026-09-01
Last Updated
2026-06-23
Healthy Volunteers
No
Conditions
Interventions
Double-Filtration Plasmapheresis With the IN300 Apheresis Device
A single clinically prescribed session of double-filtration plasmapheresis using the IN300 Inuspheresis apheresis device. Blood is withdrawn through intravenous access, passed through a primary filter that separates plasma from blood cells, and then through a secondary filter that removes particles according to the filter characteristics. The filtered plasma and blood cells are recombined and returned to the participant. The session treats approximately 0.75 plasma volumes. DFPP is prescribed by and performed at the treating clinic outside the scope of the research study.
Locations (2)
Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne
Obergünzburg, Germany
Ayus Medical Basel AG
Basel, Switzerland