FREQUENTLY ASKED
QUESTIONS

Has this device been studied in humans before?

Before the RESET-RA study, this device was evaluated in 14 RA patients at four different study sites across the US. The purpose of the RESET-RA study is to evaluate the MicroRegulator device in a larger group of patients.

Who can participate in this study?

If you have tried multiple medications and continue to experience symptoms of RA, such as joint pain and swelling, you may be eligible for the study. For more information please click the “Study Overview” tab above or click here to check if you qualify for the study.

This study is designed to enroll over 200 people altogether at multiple study sites across the United States.

What do I need to do to determine whether or not I am eligible for the RESET-RA Study?

Click here to see if you may qualify for the study. Upon qualification, you will be connected to a study coordinator who can provide you with further information. A study doctor at your nearest study location will ultimately determine your eligibility to participate in the study.

What are the screening procedures to determine my eligibility to participate in the study?

After you agree to participate in the study and sign the informed consent form, you will undergo the following screening procedures to determine if you are eligible for the study:

  • Interview by the study doctor
  • Complete symptom questionnaires
  • Undergo a joint count exam and wrist MRI scan to determine your current disease state
  • Undergo blood tests to evaluate your eligibility for the implant procedure
What are the benefits of participating in the study?

As participants in this study, the patients are partners in research and play an important role in advancing the treatment choices for RA.

By taking part in the RESET-RA clinical research study, you can try this new RA treatment, which may or may not be better than the treatment options that already exist to help your condition.

While no benefit is guaranteed, it is possible that your RA disease may get better. While it is also possible that your condition may remain unchanged or get worse, we hope the information learned from this research study will benefit other individuals with RA in the future. The participants in this study will help the researchers to learn more on the treatment options for RA.

What are the possible risks and discomforts?

Like all clinical research studies, there are some risks associated with the RESET-RA study. The safety profile of the investigational vagus nerve stimulation device is currently unknown. Patients implanted with the commercially-available vagus nerve stimulation therapy system commonly experience pain, redness and swelling at the implantation site. Rarely patients experience an infection, excessive bleeding or damage to the vagus nerve, which can lead to voice, breathing or swallowing difficulties. In some patients, stimulation of the vagus nerve may trigger symptoms such as sore throat, hoarseness, cough, nausea, dizziness, tingling or numbness near the implantation site. Your physician will review the Informed Consent Form with you, which lists the possible risks and benefits associated with the device and the RESET-RA study.

Who will pay for the procedure?

All study related costs will be covered by the sponsor of the study. The company responsible for this study is SetPoint Medical, headquartered in Valencia, California.

To learn more about the company, please visit www.setpointmedical.com.

Will I be paid if I take part in this research study?

Participants will be compensated for their time and travel associated with their participation in the study.

Can I voluntarily withdraw from the study?

Taking part in this study is voluntary. You can withdraw your consent or discontinue participation in the study at any time. Your decision to leave the study will not cause any penalty or loss of benefits to which you are entitled.

GLOSSARY OF TERMS

We understand that the decision to participate in a clinical study requires you to consider a number of factors. The scientific language used is often hard to understand. This glossary is aimed to define some of these scientific terms.

Blinded:
A blinded study is often used in studies which compare two different treatments. Blinding prevents the participant and the physician from knowing certain information about their treatment that might influence their impressions when evaluating the effectiveness of the treatment.

Control Group:
A control group is a group of patients in a clinical trial that does not receive the treatment being studied for a certain period of time, so that comparisons can be made between the two patient groups. For example, in the RESET-RA study, half of the patients will be in the control group and will receive non-therapeutic stimulation. The control group will continue to take their conventional DMARD and will undergo the same level of care as the patients who are assigned to the treatment group. The results of the control group will be compared to the results of the treatment group, and that data will be used to determine if the MicroRegulator is effective in treating the disease. Without the control group, there would be no way to compare the new treatment option to the current treatment options. After 3 months, the patients in the control group will have the option to enroll in the extension study and receive therapeutic stimulation.

FDA:
The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting public health through the regulation and supervision of health products like pharmaceutical drugs, vaccines, medical devices and veterinary products.

Investigational:
The device being evaluated in the RESET-RA clinical study is considered investigational because it is being evaluated for its safety and effectiveness. It is not approved by the United States Food and Drug Administration (FDA) for commercial use. The data collected in the RESET-RA clinical study is intended to be used to obtain FDA approval for this device.

IRB:
An Institutional Review Board (IRB), also known as an independent ethics committee or ethical review board, is a committee that approves, monitors, and reviews biomedical and behavioral research involving humans. The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and health of patients in a research study. The RESET-RA study has been approved by the IRB of the participating study sites.

Multi-Center:
A multi-center study is conducted at more than one site of patient care. For example, the RESET-RA study will enroll patients at up to 40 study sites in the USA. Multiple centers of study ensure that the study enrolls participants who are from various geographic locations and are represented by different ethnic groups and gender.

Prospective:
A prospective study observes the participants over a pre-defined time period set at the start of the study. Various results are collected at regular time intervals to measure the effectiveness of the investigational treatment.

Randomized:
A randomized study design randomly assigns participants in the study to either the control or the treatment group. A randomized design is used to prevent stacking the study groups in a way that would favor one group over the other.

Treatment Group:
A treatment group is a group of patients in a clinical study that receives the treatment being studied, so that comparisons can be made between the control and treatment groups. The patients themselves will not know which group they are assigned to until the RESET-RA study is completed.