Microplastic and Nanoplastic Particle Burden in Peripheral BloodDFPP-MNPNCT07658443
Evaluating DFPP for Microplastic and PFAS Reduction
An observational study of Microplastic and Nanoplastic Particle Burden in Peripheral Blood and Double-Filtration Plasmapheresis, run by Proxima Health, Inc. at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Microplastic and Nanoplastic Particle Burden in Peripheral Blood, Double-Filtration Plasmapheresis
- What is being tested?
- Double-Filtration Plasmapheresis With the IN300 Apheresis Device
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jun 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site
Ayus Medical Buergenstock - Buergenstock Resort Lake Lucerne
Obergünzburg
About this study
Official title: Removal of Microplastics, Nanoplastics, and PFAS From Human Peripheral Blood Via Double-Filtration Plasmapheresis
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.
Read the detailed description
Background and Rationale:
Microplastics and nanoplastics (MNPs) have been detected in human blood and every major organ. Increasingly, studies associate MNP exposure with a range of health conditions, including cardiovascular disease, metabolic disease, gastrointestinal disease, neurodegenerative disease, and cancer. There has been very little study of clinical approaches to remove MNPs from the human body. Such efforts have been limited in part by challenges in measuring MNPs in human blood, especially nanoplastics, which are too small to be detected by most equipment.
Double-filtration plasmapheresis (DFPP) is an established treatment for dozens of health conditions mediated by substances circulating in plasma. In DFPP, a first filter separates blood cells from plasma, and a second filter removes molecules from plasma according to the filter characteristics. The filtered plasma and blood cells are then recombined and returned to the patient. In 2025, a study showed that the material removed from plasma by a specialized type of DFPP called Inuspheresis with the CE-marked IN300 device includes microplastic molecules.
Per- and polyfluoroalkyl substances (PFAS) are persistent environmental chemicals that can also be measured in human blood and have been associated with a range of health conditions. This study will additionally evaluate whether circulating PFAS concentrations change after DFPP.
Study Design:
This is a single-group, open-label, prospective, within-subject observational pilot study. Approximately 20 adult participants who have already been independently prescribed DFPP by their treating clinic will be enrolled. Study samples and research data will be anonymized before research analysis.
Procedures:
Each participant provides written informed consent, then undergoes blood sampling shortly before the DFPP treatment session and again within 10 minutes of the end of the treatment session, after approximately 0.75 plasma volumes have been treated. Adverse events and tolerability observations are recorded throughout the treatment encounter. For a randomly selected subset of five participants, additional exploratory analyses will be performed on paired blood samples using pyrolysis-gas chromatography-mass spectrometry (Py-GC-MS), and a sample of DFPP eluate will be collected to assess whether plastic polymers and PFAS are present in the material removed during treatment.
Analytical Methods:
Co-Primary: Nano-flow cytometry with Nile Red staining, which has been shown in multiple studies to provide detection and counting of microplastic and nanoplastic particles down to approximately 50 nanometers in human blood.
Co-primary: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) for measurement of total quantified PFAS concentration in paired pre- and post-treatment blood samples from all participants.
Exploratory: Py-GC-MS for polymer-specific mass quantification in blood and eluate in a five-participant subset. PFAS analytes in eluate will also be evaluated in the same subset.
Statistical Analysis:
The primary analyses will evaluate within-subject change in circulating MNP particle concentration and total quantified PFAS concentration using a paired pre/post design. The primary hypothesis tests will be the Wilcoxon matched-pairs signed-rank test. Effect size will be summarized using the median within-participant percent change and geometric mean post/pre ratio with a 95% confidence interval. Based on an approximate paired-analysis power calculation, a sample size of 20 participants provides approximately 80% power to detect a large within-participant reduction on the order of 50%, assuming a two-sided alpha of 0.05 and variability of paired log post/pre ratios not materially exceeding approximately 1.0. The same paired sample size will be used to characterize the PFAS co-primary endpoint. Because this is an early paired biomarker study with two co-primary endpoints, no formal multiplicity adjustment is planned, and the co-primary p-values will be interpreted descriptively. Exploratory Py-GC-MS analyses in the five-participant subset are not powered for definitive hypothesis testing; results will be summarized using absolute and percent change. Exploratory PFAS eluate results will be summarized descriptively. Quality-control procedures include procedural blank review; values at or below the laboratory limit of quantification will be treated conservatively.
- Conditions
- Microplastic and Nanoplastic Particle Burden in Peripheral Blood, Double-Filtration Plasmapheresis
- Being tested
- Double-Filtration Plasmapheresis With the IN300 Apheresis Device
- Keywords
- microplastics, nanoplastics, DFPP, double-filtration plasmapheresis, plasmapheresis, apheresis, Inuspheresis, IN300, nano-flow cytometry, Py-GC-MS, PFAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-Filtration Plasmapheresis With the IN300 Apheresis DeviceProcedure or surgery
Also called Inuspheresis, Plasmapheresis, DFPP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Double-Filtration Plasmapheresis With the IN300 Apheresis Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Paired pre- and post-treatment blood samples will be analyzed by Py-GC-MS to measure total plastic polymer mass concentration. Results will be summarized by absolute and percent change within participants.
Measured: Baseline and post-treatment within a single treatment day; assessed in a randomly selected five-participant subset
Presence of Plastic Polymers in DFPP Eluate
In the same five-participant Py-GC-MS subset, a sample of DFPP eluate will be analyzed by Py-GC-MS to assess whether plastic polymers are detectable in the material removed during treatment.
Measured: During a single DFPP treatment session; eluate collected during DFPP
Incidence and Severity of Adverse Events and Tolerability Findings
Incidence, nature, and severity of adverse events and tolerability findings recorded during the treatment encounter, including vital-sign monitoring, symptoms, complications, and any medical interventions required.
Measured: During and immediately following the DFPP treatment session
Baseline Correlations of MNP and PFAS Levels With Demographic Characteristics
Exploratory analysis examining whether pre-treatment MNP levels in peripheral blood are associated with participant demographic characteristics. This outcome does not test treatment efficacy.
Measured: Baseline only, before DFPP
Concordance in Direction of Change Between Nano-Flow Cytometry Particle Counts and Py-GC-MS Polymer Mass
Exploratory analysis examining whether the change in MNP levels measured by nano-flow cytometry is in the same direction as the change measured by Py-GC-MS. Concordance will be summarized descriptively; no formal hypothesis testing is planned.
Measured: Baseline and post-treatment within a single treatment day; Py-GC-MS assessed in a subset of participants
Change in Individual PFAS Analyte Concentrations
Paired pre- and post-treatment EDTA whole-blood samples from all participants will be analyzed by LC-MS/MS. Within-participant absolute and percent changes in individual target PFAS analytes will be summarized descriptively. These analyses are exploratory beyond the co-primary total quantified PFAS endpoint.
Measured: Baseline and post-treatment within a single treatment day; post-treatment sample collected within 10 minutes of completion of DFPP.
Presence and Quantity of PFAS Analytes in DFPP Eluate
In the same five-participant exploratory subset used for Py-GC-MS analysis, a sample of DFPP eluate will be analyzed by LC-MS/MS to assess the presence and quantity of PFAS analytes in material removed during treatment. Results will be summarized descriptively and interpreted as supportive or mechanistic evidence rather than as a powered endpoint.
Measured: During a single DFPP treatment session; eluate collected during DFPP.
Association Between Baseline MNP and PFAS Levels
Exploratory analysis examining whether baseline pre-treatment MNP concentration measured by nano-flow cytometry is associated with baseline total quantified PFAS concentration measured by LC-MS/MS. Associations will be summarized descriptively and may be evaluated using rank-based correlation methods.
Measured: Baseline only, before DFPP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start12 Jun 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microplastic and Nanoplastic Particle Burden in Peripheral BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proxima Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ayus Medical Devices AG
- Responsible party
- Sponsor
- Investigators
- Michael Petegorsky, Study director, Proxima Health, Inc.Matthew Amsden, Study director, Efforia, IncJordi Petriz, PhD, Principal investigator, Institut de Recerca Germans Trias i Pujol (IGTP)Stefan Bornstein, MD, Principal investigator, University Hospital Carl Gustav Carus, Technische Universitaet Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658443
- Sponsor's protocol ID
- 91252
- Other IDs
- Efforia-DFPP-MNP-Pilot
- Acronym
- DFPP-MNP
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual-level results will be returned directly to participants. Aggregate and de-identified findings will be published or otherwise made publicly available after study completion. No formal plan is currently established to share individual participant data with external researchers for this pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Microplastics, Nanoplastics, and PFAS From Human Peripheral Blood Via Double-Filtration Plasmapheresis
- ClinicalTrials.gov ID
- NCT07658443
- Acronym / sponsor ID
- DFPP-MNP / 91252
- Conditions
- Microplastic and Nanoplastic Particle Burden in Peripheral Blood, Double-Filtration Plasmapheresis
- Keywords
- microplastics, nanoplastics, DFPP, double-filtration plasmapheresis, plasmapheresis, apheresis, Inuspheresis, IN300
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Proxima Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ayus Medical Devices AG
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Microplastics and nanoplastics (MNPs) have been detected in human blood and every major organ. Increasingly, studies associate MNP exposure with a range of health conditions, including cardiovascular disease, metabolic disease, gastrointestinal disease, neurodegenerative disease, and cancer. There has been very little study of clinical approaches to remove MNPs from the human body. Such efforts have been limited in part by challenges in measuring MNPs in human blood, especially nanoplastics, which are too small to be detected by most equipment.
Double-filtration plasmapheresis (DFPP) is an established treatment for dozens of health conditions mediated by substances circulating in plasma. In DFPP, a first filter separates blood cells from plasma, and a second filter removes molecules from plasma according to the filter characteristics. The filtered plasma and blood cells are then recombined and returned to the patient. In 2025, a study showed that the material removed from plasma by a specialized type of DFPP called Inuspheresis with the CE-marked IN300 device includes microplastic molecules.
Per- and polyfluoroalkyl substances (PFAS) are persistent environmental chemicals that can also be measured in human blood and have been associated with a range of health conditions. This study will additionally evaluate whether circulating PFAS concentrations change after DFPP.
Study Design:
This is a single-group, open-label, prospective, within-subject observational pilot study. Approximately 20 adult participants who have already been independently prescribed DFPP by their treating clinic will be enrolled. Study samples and research data will be anonymized before research analysis.
Procedures:
Each participant provides written informed consent, then undergoes blood sampling shortly before the DFPP treatment session and again within 10 minutes of the end of the treatment session, after approximately 0.75 plasma volumes have been treated. Adverse events and tolerability observations are recorded throughout the treatment encounter. For a randomly selected subset of five participants, additional exploratory analyses will be performed on paired blood samples using pyrolysis-gas chromatography-mass spectrometry (Py-GC-MS), and a sample of DFPP eluate will be collected to assess whether plastic polymers and PFAS are present in the material removed during treatment.
Analytical Methods:
Co-Primary: Nano-flow cytometry with Nile Red staining, which has been shown in multiple studies to provide detection and counting of microplastic and nanoplastic particles down to approximately 50 nanometers in human blood.
Co-primary: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) for measurement of total quantified PFAS concentration in paired pre- and post-treatment blood samples from all participants.
Exploratory: Py-GC-MS for polymer-specific mass quantification in blood and eluate in a five-participant subset. PFAS analytes in eluate will also be evaluated in the same subset.
Statistical Analysis:
The primary analyses will evaluate within-subject change in circulating MNP particle concentration and total quantified PFAS concentration using a paired pre/post design. The primary hypothesis tests will be the Wilcoxon matched-pairs signed-rank test. Effect size will be summarized using the median within-participant percent change and geometric mean post/pre ratio with a 95% confidence interval. Based on an approximate paired-analysis power calculation, a sample size of 20 participants provides approximately 80% power to detect a large within-participant reduction on the order of 50%, assuming a two-sided alpha of 0.05 and variability of paired log post/pre ratios not materially exceeding approximately 1.0. The same paired sample size will be used to characterize the PFAS co-primary endpoint. Because this is an early paired biomarker study with two co-primary endpoints, no formal multiplicity adjustment is planned, and the co-primary p-values will be interpreted descriptively. Exploratory Py-GC-MS analyses in the five-participant subset are not powered for definitive hypothesis testing; results will be summarized using absolute and percent change. Exploratory PFAS eluate results will be summarized descriptively. Quality-control procedures include procedural blank review; values at or below the laboratory limit of quantification will be treated conservatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFPP Treatment Group | – | Procedure: Double-Filtration Plasmapheresis With the IN300 Apheresis DeviceAdults 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double-Filtration Plasmapheresis With the IN300 Apheresis DeviceAlso: Inuspheresis, Plasmapheresis, DFPPA 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. | Procedure or surgery | DFPP Treatment Group |
Primary outcome
Change in Circulating Microplastic and Nanoplastic Particle Concentration
Time frame: Baseline immediately before DFPP and post-treatment within 10 minutes of the end of the DFPP session, within a single treatment day
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.
Change in Circulating PFAS Concentration
Time frame: Baseline immediately before DFPP and post-treatment within 10 minutes of the end of the DFPP session, within a single treatment day
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.
8 secondary outcomes
Change in Total Plastic Polymer Mass Concentration by Py-GC-MS in a Subset of 5 Participants
Time frame: Baseline and post-treatment within a single treatment day; assessed in a randomly selected five-participant subset
Presence of Plastic Polymers in DFPP Eluate
Time frame: During a single DFPP treatment session; eluate collected during DFPP
Incidence and Severity of Adverse Events and Tolerability Findings
Time frame: During and immediately following the DFPP treatment session
Baseline Correlations of MNP and PFAS Levels With Demographic Characteristics
Time frame: Baseline only, before DFPP
Concordance in Direction of Change Between Nano-Flow Cytometry Particle Counts and Py-GC-MS Polymer Mass
Time frame: Baseline and post-treatment within a single treatment day; Py-GC-MS assessed in a subset of participants
Change in Individual PFAS Analyte Concentrations
Time frame: Baseline and post-treatment within a single treatment day; post-treatment sample collected within 10 minutes of completion of DFPP.
Presence and Quantity of PFAS Analytes in DFPP Eluate
Time frame: During a single DFPP treatment session; eluate collected during DFPP.
Association Between Baseline MNP and PFAS Levels
Time frame: Baseline only, before DFPP.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual-level results will be returned directly to participants. Aggregate and de-identified findings will be published or otherwise made publicly available after study completion. No formal plan is currently established to share individual participant data with external researchers for this pilot study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Petegorsky study director
Proxima Health, Inc.
Matthew Amsden study director
Efforia, Inc
Jordi Petriz, PhD principal investigator
Institut de Recerca Germans Trias i Pujol (IGTP)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microplastic and Nanoplastic Particle Burden in Peripheral Blood and Double-Filtration Plasmapheresis, run by Proxima Health, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Circulating Microplastic and Nanoplastic Particle Concentration (time frame: Baseline immediately before DFPP and post-treatment within 10 minutes of the end of the DFPP session, within a single treatment day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.