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Who is sponsoring this study?

EnteroMedics Inc.

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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 participants 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 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.

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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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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.

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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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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.

 

 
VBLOC Therapy
Study Sponsor: EnteroMedics