The purpose of this pilot study is to evaluate whether one DFPP treatment session changes the amount of microplastics and nanoplastics circulating in human blood.

DFPP stands for double-filtration plasmapheresis. It is a blood-filtering treatment in which blood is removed through venous access, the plasma portion is separated and filtered through a specialized device, and filtered blood components are returned to your body. In this study, DFPP is performed using the IN300 apheresis device.

The main outcome measure is the change in microplastic and nanoplastic concentration in your blood before and after treatment. The main laboratory method is nano-flow cytometry with Nile Red staining. In simpler terms, this is a specialized laboratory test used to detect and count very small plastic particles in blood samples.

A smaller random subset of participants, expected to include 5 participants, will also have samples of blood and eluate tested with pyrolysis gas chromatography-mass spectrometry, also called Py-GC-MS. Eluate is material removed from plasma during DFPP. Py-GC-MS is another laboratory method that may help identify and measure specific plastic materials. It is being used here as an additional confirmation method in a subset of samples.

The study also looks at safety and tolerability during the treatment session.

You are being asked to participate because you are an adult who has already been prescribed DFPP outside this study and may be willing to provide research samples and information before, during, and after that treatment.

You should not participate unless you understand that DFPP is separate from the research study, you have had the opportunity to discuss DFPP risks and benefits with your treating clinician, and you are comfortable providing research samples and information.

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures.
• Tell clinic staff about any side effects or problems.
• Share any problems with help@efforia.com if you do not feel comfortable speaking to clinic staff.
• Ask questions as you think of them through help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

Once you have completed enrollment and entered your personal details and communication preferences, the study will involve the following:

• You will review and sign informed consent.
• You will confirm that you have already been prescribed DFPP outside the study.
• You will attend one outpatient DFPP treatment session.
• Blood samples will be collected shortly before treatment begins.
• Blood samples will be collected again shortly after treatment ends.
• Your vital signs will be monitored during the DFPP session.
• Any side effects, symptoms, or adverse events will be recorded.
• If you are selected for the exploratory subset, additional laboratory testing may be performed on your paired samples, and a sample of material removed during DFPP may also be collected for analysis. No additional action is required of you.

The treatment session is expected to involve approximately one DFPP session treating about 0.66 to 1 plasma volume.

This study is designed as a within-subject pre-treatment and post-treatment comparison. This means your before-treatment and after-treatment samples are compared to each other.

Blood collection will take place through venous access already established for your apheresis treatment, when clinically and operationally feasible.

Two research blood samples are expected to be collected: one at the beginning of treatment and one at the end of treatment. Based on the clinical facility information currently available, each blood sample is expected to be approximately 6 mL, for a total of approximately 12 mL of blood.

Eluate may be collected from the collection bag at the end of treatment. Based on the clinical facility information currently available, the eluate sample is expected to be approximately 12 mL.

The amount of blood collected is expected to be medically safe and should not affect or prolong your treatment.

IRB note requiring protocol specificity before final use: The final protocol and consent should confirm the exact timing of each blood draw, exact blood volume per draw, total research blood volume, whether samples are drawn only through existing venous access or may require separate venipuncture, whether eluate is collected from all participants or only a subset, whether any follow-up contact occurs after the DFPP session, and which clinical/treatment-session data are recorded for research.

IRB note requiring device disposition clarity: The protocol should clarify what happens after treatment to any DFPP-related devices or device components that may contain biological material or filtered material, including filters, cartridges, tubing, collection bags, eluate containers, or other device components. The protocol should state whether these items are discarded as clinical waste, retained for research inspection or testing, returned to the clinical facility, transferred to a laboratory, stored, photographed, or otherwise used after treatment. If no devices or components are retained for research, the consent and protocol should say so clearly.

This section describes the risks added by the research study itself. DFPP-related clinical risks are described separately below.

You are already being prescribed DFPP independent of this study. The research study is expected to add risks related mainly to research blood collection, research sample handling, research results, privacy, and data security.

Research blood collection risks may include:

• Temporary pain or discomfort from blood collection.
• Bruising, bleeding, swelling, or irritation at the collection site.
• Lightheadedness or fainting.
• Infection, which is uncommon but possible whenever blood is drawn or vascular access is used.

Research result risks may include anxiety, concern, confusion, or misunderstanding if your microplastic or nanoplastic results are difficult to interpret. Your individual results should be considered research and personal information results only. They are not diagnostic results and should not be used as treatment guidance.

Privacy and security risks are described in more detail in the privacy and data sections of this consent. No system can guarantee complete privacy or security.

It is possible that not all research risks are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Please do not join unless you believe the possible benefits, the purpose of the study, and the remaining uncertainty are acceptable to you personally.

DFPP itself has risks, but DFPP is prescribed and performed outside this study. The study does not prescribe, recommend, provide, pay for, arrange, change, or control your DFPP treatment. The clinical facility and treating clinician are responsible for clinical screening, DFPP treatment decisions, clinical monitoring, and management of DFPP-related risks.

You should discuss the risks, possible benefits, and alternatives to DFPP with your treating clinician before receiving DFPP.

Possible DFPP-related risks may include, depending on your health, the device used, the treatment procedure, and clinical judgment:

• Lightheadedness, tiredness, feeling cold, nausea, numbness, or tingling.
• Low blood pressure.
• Changes in calcium, magnesium, temperature, or other blood chemistry measures.
• Bleeding, bruising, vascular access problems, or discomfort related to venous access.
• Infection.
• Allergic reaction to fluids, materials, medications, or replacement products used during treatment.
• Clotting in the machine or tubing.
• Temporary changes in blood proteins, including proteins involved in clotting.
• Other unexpected or currently unknown risks.

Since blood collection is expected to take place through venous access already established for apheresis treatment, the study is not expected to add risks beyond the research blood draw and research-related privacy, data, and result-interpretation risks described above.

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as zero risk. Before participating, you should review the Efforia general privacy policy here: https://efforia.com/privacy-policy/

There are also limits to privacy. For example, we may reach out to local help if we have reason to believe you may be a danger to yourself or others. Regulators, such as the FDA or similar agencies, Institutional Review Boards, and research oversight bodies may review records that include identifying information if needed to ensure the study is being conducted properly.

The researchers will only use and share information that is needed for the study. The researchers will protect your information, as required by law. Absolute confidentiality cannot be guaranteed because persons outside the study team may need to look at your study records.

The Efforia Institutional Review Board may review your study records, and other agencies, committees, and offices that review and monitor research studies may also review your study records. The purpose for using and sharing your information is to make sure the study is done properly.

By signing this consent form, you are giving permission for Efforia to use and share your health information. If you decide not to sign the form, you cannot be in the study.

Efforia will provide you with personal outcomes as well as overall findings from the study as data become available. These findings may be shared with you at different points during your study experience or when Efforia identifies meaningful results.

Your individual results will be returned to you. These results should be considered research and personal information results. They are not diagnostic results and should not be used as treatment guidance.

The results may affect your interest in continuing in the study. Participation remains voluntary, and you may leave the study at any time by contacting help@efforia.com.

Possible benefits include:

• Learning whether DFPP appeared to change your blood microplastic or nanoplastic measurements.
• Receiving structured personal data about your experience.
• Helping generate broader knowledge that may benefit future participants and the public.

There is also a possibility that there will be no measurable benefit to you, other than learning that the intervention had no measurable impact.

If you believe you have a study-related injury or side effect, seek local medical care first if needed. Efforia cannot provide emergency medical care or diagnosis.

After you have received any necessary care, it is very important that you contact Efforia at help@efforia.com to report what happened. Efforia wants to understand possible risks, support proper reporting, and help protect other participants.

Efforia will not offer financial compensation nor absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any study related injury as a result of participation in this study.

In the case of a medical emergency, dial local emergency medical care immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in-person medical assistance immediately.

If at any time you feel like you may be a danger to yourself or others, please seek mental healthcare immediately.

Because this study is for research, the main alternative is simply not to be in the study.

Your decision about research participation is separate from your decision about DFPP clinical care. You may still receive DFPP, if prescribed and arranged by your treating clinician, even if you do not join this study.

If this study does not seem right for your goals, situation, or comfort level, Efforia is dedicated to making other studies available. You may click the Efforia logo in the upper portion of the page to explore other studies that may be more appropriate.

Ethical Considerations

Efforia upholds high ethical standards in research. Your participation in this study is completely voluntary, and you are free to withdraw at any time without adverse consequences. You are not giving up any rights by signing this document.

Participant Rights

Your participation in this research study is voluntary. Refusing to participate will not alter your usual health care or involve any penalty or loss of benefits to which you are entitled. If you decide to join the study, you may withdraw at any time and for any reason without penalty or loss of benefits.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through measures designed to reduce unauthorized access and misuse.

The Right to Leave a Study Without Penalty at Any Time

If you decide to withdraw from the study, you may do so at any time by contacting help@efforia.com or by using the available leave-study functionality on the Efforia platform, if enabled for this protocol.

Because participation through Efforia costs $0 for this protocol, there is no Efforia purchase price to refund. If you incur separate clinical costs outside Efforia related to DFPP, those arrangements are outside this study and outside Efforia’s control.

Efforia collects data from your consent process, study participation, laboratory results, adverse event reporting, and related study tasks. This data is used to operate the study, provide personal results, and generate overall study findings. Data will be stored and handled using privacy and security practices intended to comply with applicable data protection requirements. Even with those protections, no system can guarantee complete privacy or security.

What you can do to improve your privacy and security

As part of participating in this study, you may receive notifications by e-mail, SMS, or push notification when new study tasks, reminders, or updates are available. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study and you will not receive study notifications.

To help prevent others from seeing your study-related information, you should make sure your phone, desktop computer, and e-mail accounts are protected by a password, PIN, or other access control. You should also avoid sharing your accounts or passwords with others.

This study is hosted on Efforia and is governed by privacy and confidentiality standards intended to put you in control. You can learn more here: https://efforia.com/privacy-policy

Who will have access to your data?

Efforia will have access to your study data. Partners involved in study operations may also have access to limited data as needed, such as laboratories, treatment providers, data processors, and connected health technology providers, if used in connection with this study.

What will we do with your data?

We will use your data to show you your own personal results, combine your results with those of other participants to produce overall findings, and operate, monitor, and report on the study appropriately. We will not publicly use your information with your name or other direct identifiers without your permission.

Research samples and data may be coded or anonymised for research purposes. Where anonymisation is used, information that could directly identify you, such as name, date of birth, or patient number, is removed so that samples or data are not intended to be traced back to you.

If samples are completely and irreversibly anonymised, withdrawal is no longer technically possible because the samples can no longer be assigned to you. If samples are still identifiable or coded in a way that can be linked back to you, you may withdraw consent and request destruction of samples that have not yet been anonymised, to the extent allowed by applicable law and study procedures.

Samples will be stored under controlled conditions for a maximum of 10 years. Use is exclusively for scientific research purposes. Commercial use is excluded. After completion of research projects, samples will be disposed of appropriately.

The requirements of applicable data protection law, including the Swiss Data Protection Regulation and Federal Data Protection Act where applicable, will be followed.

IRB note requiring final confirmation: The final study documents should confirm whether samples are coded, pseudonymised, or fully anonymised at each stage; who, if anyone, holds the linkage key; when anonymisation occurs; where samples are stored; whether samples or data are transferred outside Switzerland or the European Economic Area; and whether any leftover material remains after testing.

As part of Efforia’s commitment to ethical conduct and transparency, it is important to explain the structure of this study. This research experience is hosted on Efforia, but the treatment decision and prescription happen outside the study.

This study is sponsored by Proxmia Health. Efforia serves as the platform and system used to participate in the study and does not sponsor or influence the study outcomes.

For this specific protocol, participant cost through Efforia is $0. More generally, Efforia’s business model may include transaction fees on products and services associated with protocols hosted on its platform. Other than that platform-fee model, Efforia has no financial interest in the outcome of this study.

To further reduce conflicts of interest, Efforia will remind you once if you do not complete enrollment. Efforia will not repeatedly market this study to you or otherwise push you to join.

How we Reduce Conflicts of Interest

Participants also have a role in reducing conflicts of interest. You should not join this study if you have a financial relationship with the intervention providers, treatment providers, measurement providers, or protocol authors connected to this trial. This includes being an employee, investor, stakeholder, paid advisor, or protocol author associated with those entities. Participation under such conflicts could compromise the integrity of the study and the validity of the results.

Consequences of Conflict of Interest Non-Compliance

If you fail to disclose a relevant conflict of interest, or if a breach of this policy is discovered, you may be suspended from the platform and payments may not be refunded where applicable.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

This study has been reviewed by the Efforia Institutional Review Board, also called the Efforia IRB. The IRB is a group of independent experts who help protect the rights, safety, and well-being of research participants.

If you have questions about your rights as a participant, or would like to speak with someone outside the research team, you can contact the IRB at ethics@efforia.com.

Efforia and Efforia IRB have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Efforia IRB have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.

If you have study questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.

If you have clinical questions about DFPP or your medical treatment, please contact Ayus Medical Basel AG at +41 61 381 85 85 or clinic.basel@ayus.health.

Efforia has approved the information in this consent form and has given approval to publish this study. This does not mean Efforia has approved or endorses your being in the study. You must consider the information in this consent form and do additional research based on your own situation for yourself and decide if you want to and are appropriate for this study.

If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.