Frequently Asked Questions

Will I receive any payment to participate in the study?

Is there a cost associated with participating in this study?

If I participate, how many times do I have to go back to the doctor's office and how long is the study?

May I speak on behalf of another person?

Is there a control/placebo group in this clinical trial?

Will the device cause temporary or long-term side effects?

Will the device cause me to be unable to eat certain foods during the study?

Can women who are pregnant or nursing participate in the study?

When will I know if I am eligible?

Where is the study being conducted in my area?

How will my medical information be kept confidential?

Are clinical research studies safe?

Why might I be excluded from the study?

Do you know of any other clinical studies?

What if I get in the study and I decide I do not want to participate anymore? Can I drop out?

1.) Who is sponsoring this study?

EnteroMedics Inc.

2.) Will I receive any payment to participate in the study?

You will not be reimbursed for your participation in the study. Your site coordinator will provide details of any other reimbursements that may be available.

3.) Is there a cost associated with participating in this study?

There will be no added costs to you for participating in this study.

4.) If I participate, how many times do I have to go back to the doctor's office and how long is the study?

This is a five-year study. There are 50 planned visits over this period of time, with 20 visits required during the first year of the study. Additional details regarding scheduled visits are available from the study site.

5.) May I speak on behalf of another person?

No, the nurse will need to speak to the potential study individual directly to determine if she/he is willing to consider participating in the pre-screening process and in this study.

6.) What is being tested?

VBLOC Therapy for weight loss.

7.) How does VBLOC Therapy work?

VBLOC Therapy is delivered by an implantable device intended to block signals carried on the vagus nerve between the brain and the digestive system that control sensations of hunger, satisfaction and fullness. Specifically, studies have shown that blocking the vagal nerve signals using VBLOC Therapy helps patients control hunger sensations and results in early fullness at meals compared to before they received the device.

The device itself uses laparoscopically-implanted electrodes that deliver high-frequency, low-energy electrical impulses to block the signals conveyed through the vagal (vagus) nerves. By being able to reversibly control these signals, VBLOC Therapy may aid in weight loss.

VBLOC Therapy may be turned off and is designed to be reversible, programmable and non-invasively adjustable.

8.) Is there a control/placebo group in this clinical trial?

Everyone who is eligible to enroll in the trial and sign the Informed Consent will have the device implanted. One-third of the study participants will be randomly selected (randomized) to have a non functioning device implanted for the first year, and the remaining two-thirds will be randomly selected to have a fully functioning device. After most participants have completed one year of follow-up, if you were in the control group, you may choose to have a fully functioning device implanted during a second surgery. The selection as to which group a participant is assigned is totally random, and there is no way to influence to which group you would be assigned.

9.) Will the device cause temporary or long-term side effects?

There are always risks associated with any devices. It would be best to speak to your physician as to what risks/side effects that would apply to you with your current medical condition.

10.) Will the device cause me to be unable to eat certain foods during the study?

There is no specific list of foods you will be unable to eat. There is no plan to use pureed foods or adhere to a liquid diet as a study participant. The weight management program in which all study participants will be involved will provide advice on a healthy diet and exercise.

11.) Can women who are pregnant or nursing participate in the study?

No, since the risks to the fetus for some of the study procedures are unknown, women who are nursing, pregnant or planning a pregnancy should not participate in the study.

12.) When will I know if I am eligible?

If you meet the initial prescreening criteria and have given your permission to provide your contact information to the research site in your area, the study site will be able to determine your eligibility.

13.) Where is the study being conducted in my area?

Before information can be provided to the study site that is participating in the clinical research study, you will need to complete a questionnaire with a nurse by phone to see if you meet the initial prescreening criteria for the study.

14.) How will my medical information be kept confidential?

The information gathered in this study may also be used in research and development projects designed to investigate approaches diagnosing and treating diseases. Your identity will never be disclosed in connection with these research and developments. Your information may also be used in articles intended for publication in scientific journals and in scientific meetings; however, no publication or presentation at a scientific meeting about the research will reveal your identity without your specific written permission. These limitations continue even if you revoke (take back) your authorization

15.) Are clinical research studies safe?

Before participating in a clinical research study, a person must agree to sign an Informed Consent form, which provides detailed information about the safety of a study and study procedures. For more information on clinical research studies, visit: www.clinicaltrials.gov/ct/info.

16.) Why might I be excluded from the study?

Researchers need to evaluate the device in people whose medical histories are quite similar. This helps the researchers determine if the study device is working. If your answers to the survey questions indicate that this study’s eligibility criterion does not fit with your medical history profile, you will be excluded from the study.

17.) Do you know of any other clinical studies?

To find out about other clinical research studies, please visit www.clinicaltrials.gov, www.centerwatch.com, or www.searchclinicaltrials.org.

18.) What if I get in the study and I decide I do not want to participate anymore? Can I drop out?

If you decide you do not want to be in this study your decision will not affect your medical care or affect your relationship with any of your doctors.

For more information about VBLOC Therapy and the ReCharge clinical research study, please visit www.enteromedics.com