Evaluating DFPP for Microplastic and PFAS Reduction

NCT07658443 | Enrolling By Invitation FDA Device

• 2 other identifiers: 91252Efforia-DFPP-MNP-Pilot
• Study Type: observational
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

microplastics; nanoplastics; DFPP; double-filtration plasmapheresis; plasmapheresis; apheresis; Inuspheresis; IN300; nano-flow cytometry; Py-GC-MS; PFAS

Outcome Measures

Primary Outcomes (2)

• Change in Circulating Microplastic and Nanoplastic Particle Concentration

  Within-subject change in total microplastic and nanoplastic particle concentration in peripheral blood, measured by nano-flow cytometry with Nile Red staining and reported as particles per unit volume, absolute change, percent change, and post/pre ratio. Pre-treatment and post-treatment blood samples are compared within each participant.

  Baseline immediately before DFPP and post-treatment within 10 minutes of the end of the DFPP session, within a single treatment day

• Change in Circulating PFAS Concentration

  Within-subject change in total quantifiable PFAS concentration in peripheral blood, measured by LC-MS/MS and reported as particles per unit volume, absolute change, percent change, and post/pre ratio. Pre-treatment and post-treatment blood samples are compared within each participant.

  Baseline immediately before DFPP and post-treatment within 10 minutes of the end of the DFPP session, within a single treatment day

Secondary Outcomes (8)

• Change in Total Plastic Polymer Mass Concentration by Py-GC-MS in a Subset of 5 Participants

  Baseline and post-treatment within a single treatment day; assessed in a randomly selected five-participant subset

• Presence of Plastic Polymers in DFPP Eluate

  During a single DFPP treatment session; eluate collected during DFPP

• Incidence and Severity of Adverse Events and Tolerability Findings

  During and immediately following the DFPP treatment session

• Baseline Correlations of MNP and PFAS Levels With Demographic Characteristics

  Baseline only, before DFPP

• Concordance in Direction of Change Between Nano-Flow Cytometry Particle Counts and Py-GC-MS Polymer Mass

  Baseline and post-treatment within a single treatment day; Py-GC-MS assessed in a subset of participants

Study Arms (1)

DFPP Treatment Group

Adults aged 18 to 80 who have already been independently prescribed DFPP by their treating clinic, independent of research participation. Each participant undergoes one DFPP treatment session with paired pre- and post-treatment blood sampling. A randomly selected subset of five participants will also provide samples for exploratory Py-GC-MS analysis and eluate collection.

Procedure: Double-Filtration Plasmapheresis With the IN300 Apheresis Device

Interventions

Double-Filtration Plasmapheresis With the IN300 Apheresis Device PROCEDURE

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.

Also known as: Inuspheresis, Plasmapheresis, DFPP

DFPP Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 to 80 who have already been independently prescribed and medically cleared for DFPP by a qualified treating clinic and who are willing and able to provide paired pre- and post-treatment blood samples.

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

Sponsors & Collaborators

• Proxima Health, Inc.: lead
• Ayus Medical Devices AG: collaborator

Study Sites (2)

Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne

Obergünzburg, Germany

Location

Ayus Medical Basel AG

Basel, 4051, Switzerland

Location

MeSH Terms

Interventions

Plasmapheresis

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Michael Petegorsky

  Proxima Health, Inc.

  STUDY DIRECTOR

• Matthew Amsden

  Efforia, Inc

  STUDY DIRECTOR

• Jordi Petriz, PhD

  Institut de Recerca Germans Trias i Pujol (IGTP)

  PRINCIPAL INVESTIGATOR

• Stefan Bornstein, MD

  University Hospital Carl Gustav Carus, Technische Universitaet Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 22, 2026
• Study Start: June 12, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1)