Who is sponsoring
this study?
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?
What is being tested?
How does VBLOC
Therapy work?
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?
Can you tell me
more about the study’s goals or objectives?
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?
Who is sponsoring this study?
EnteroMedics Inc.
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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.
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Is there a cost associated with participating in this
study?
There will be no added costs to you for participating
in this study. Once
you are no longer participating in this study, you will
be responsible for all costs of your medical care.
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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 43 planned visits
over this period of time, with 21 visits required during
the first year of the study. Additional details regarding
scheduled visits are available from the study site.
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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.
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What is being tested?
VBLOC™ Therapy for weight loss.
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How does VBLOC Therapy work?
VBLOC Therapy is delivered by an implantable, investigational
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.
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 includes both external and implanted components.
VBLOC Therapy may be turned off and is designed to be reversible,
programmable and non-invasively adjustable.
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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 the device turned OFF for the first year, and the
remaining two-thirds will be randomly selected to have
the device turned on. Diabetic patients will be implanted
and will be randomized so that 50 percent (one-half) will
have the device turned OFF for the first year. 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.
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Will the device cause temporary or
long-term side effects?
There are always risks associated with any device. 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.
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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 medical weight
program in which all study participants will be involved
will provide advice on a healthy diet and exercise.
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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.
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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.
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Where is the study
being conducted in my area?
After you complete a questionnaire with a nurse by phone
to see if you meet the initial prescreening criteria for
the study, the cities in which the study is being performed
will be disclosed to you.
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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.
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Can you tell me more about
the study’s goals or objectives?
The study’s goal is to evaluate the safety and effectiveness
of using VBLOC™ Therapy for weight loss. VBLOC™ Therapy
is delivered by a neuromodulation system consisting of
external components and surgically-implanted components.
It has the potential to deliver intermittent, controllable
electrical blocking algorithms to the intra-abdominal vagus
nerve for the treatment of obese patients who have not
responded to standard medical management.
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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.
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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.
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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.
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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.
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For more information about VBLOC Therapy and the EMPOWER
clinical research study, please call the nurse-staffed
information line at 1-866-291-9146 Monday–Thursday,
7 a.m.–7 p.m.
and Friday, 7 a.m.–6 p.m., CST.
CAUTION: Investigational device. Limited by Federal law
to investigational use.
