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ENROLLING BY INVITATION
NCT07658443

Evaluating DFPP for Microplastic Reduction

Sponsor: Efforia, Inc

View on ClinicalTrials.gov

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

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 Blood is withdrawn through intravenous access, passed through a primary filter that separates plasma from blood cells, and then through a secondary filter that removes particles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

Locations (2)

Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne

Obergünzburg, Germany

Ayus Medical Basel AG

Basel, Switzerland