Who is sponsoring
this study?
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
participants to be unable to eat certain foods during
the study?
Can women
who are pregnant or nursing participate in the study?
How will
medical information be kept confidential?
Can you tell me
more about the study’s goals or objectives?
Are clinical
research studies safe?
Who is sponsoring this study?
EnteroMedics Inc.
Back to top
What is being tested?
VBLOC™ Therapy for weight loss.
Back to top
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.
Back to top
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
participants would be assigned.
Back to top
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.
Back to top
Will the device cause participants
to be unable to eat certain foods during the study?
There is no specific list of foods participants 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.
Back to top
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.
Back to top
How will 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. Participant
identity will never be disclosed in connection with these
research and developments. 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 participant identity without specific
written permission. These limitations continue even if
participants revoke (take back) authorization.
Back to top
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.
Back to top
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.
Back to top
The EMPOWER clinical research study
is not currently recruiting patients. To learn more about
the status of the study and to view periodic clinical updates,
visit http://ir.enteromedics.com/ where
you may view recent press releases from the study sponsor.
CAUTION: Investigational device. Limited by Federal law
to investigational use.
