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Enrolling By Invitation
NCT07658443
Evaluating DFPP for Microplastic and PFAS Reduction
Conditions: Microplastic and Nanoplastic Particle Burden in Peripheral Blood, Double-Filtration Plasmapheresis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Enrollment: 20
Sponsor: Proxima Health, Inc.
Location: Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne Obergünzburg
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07658443). StuddyBuddy aggregates publicly available trial information.