Evaluating DFPP for Microplastic and PFAS Reduction

Enrolling by invitation

Conditions studied: Microplastic and Nanoplastic Particle Burden in Peripheral Blood, Double-Filtration Plasmapheresis

In brief

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.

Key facts

Study ID

NCT07658443

Run by

Proxima Health, Inc.

People needed

20

Starts

2026-06-12

Expected to finish

2026-09-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 80 years
• Body weight greater than 40 kg (approximately 88 lb)
• Already independently prescribed DFPP treatment by a qualified treating clinic
• Able to understand the study and provide voluntary informed consent
• Willing and able to provide blood samples before and after DFPP treatment
• Cleared for DFPP by the prescribing clinic
• Has not had plasmapheresis treatment within the past 7 days

You may not qualify if…

• Not yet prescribed DFPP by a treating clinic
• Major heart or circulatory problems, such as recent myocardial infarction or hypertensive crisis
• Serious kidney or liver impairment
• Blood-clotting disorders or significantly impaired coagulation
• Active infection, inflammation, or fever
• Severe frailty or very poor medical condition
• Anemia with hemoglobin below 8 g/dL
• Body weight under 40 kg
• Pregnancy or breastfeeding
• Determined by the treating clinic to be medically or mentally inappropriate for DFPP

Where it is running

• Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne — Obergünzburg, Germany
• Ayus Medical Basel AG — Basel, Switzerland

Full record on ClinicalTrials.gov

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