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Evaluating DFPP for Microplastic and PFAS Reduction

NCT07658443 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Microplastic and Nanoplastic Particle Burden in Peripheral Blood
  • Double-Filtration Plasmapheresis

Interventions

PROCEDURE

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 Blood is withdrawn through intravenous access, passed through a primary filter that separates plasma from blood cells, and then through a secondary filter that removes particles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.

Sponsors & Collaborators

  • Ayus Medical Devices AG

    collaborator UNKNOWN

  • Proxima Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Petegorsky · Proxima Health, Inc.

  • Matthew Amsden · Efforia, Inc

  • Jordi Petriz, PhD · Institut de Recerca Germans Trias i Pujol (IGTP)

  • Stefan Bornstein, MD · University Hospital Carl Gustav Carus, Technische Universitaet Dresden

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-12
Primary Completion
2026-08-01
Completion
2026-09-01
FDA Device
Yes

Countries

  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658443 on ClinicalTrials.gov