Evaluating DFPP for Microplastic and PFAS Reduction

This prospective, non-interventional, within-subject paired biomarker study will evaluate whether circulating microplastic and nanoplastic-associated particle concentrations and PFAS 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 endpoints are within-participant change in microplastic and nanoplastic-associated particle concentration measured by nano-flow cytometry with Nile Red staining, and PFAS concentration measured by LC-MS/MS. 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, and LC-MS/MS to evaluate the presence of PFAS in eluate. DFPP treatment decisions and procedural parameters are determined solely by the treating physician as part of routine care.

NCT Number	NCT07658443
Lead Sponsor	Proxima Health, Inc. Collaborators: Ayus Medical Devices AG
Conditions	Microplastic and Nanoplastic Particle Burden in Peripheral Blood, Double-Filtration Plasmapheresis
Enrollment	20 participants
Start Date	2026-06-12
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-24