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Device Blocking Stomach Nerve Signals Shows Promise in Obesity
Date:6/26/2008

g. But the patient flips a switch to activate the VBLOC device when the system is worn during the daytime hours so that the blocking signal can influence how the stomach functions and food is digested following a meal.

The lead wires are implanted in the abdomen laparoscopically, with electrodes attached to the vagal nerves and the neuroregulator, a pacemaker-sized device, is implanted just under the skin. While gastric bypass involves removing portions of the digestive tract and rerouting the flow of food and, therefore, is not reversible, the VBLOC delivery system can be removed if desired, and previous studies in animals have indicated that it does not damage or permanently affect the vagal nerves. With VBLOC, there is no distortion of digestive system anatomy as is the case with both gastric bypass and gastric banding, and to date there have been no significant issues related to food intolerance, nausea or vomiting as is common with both bypass and banding.

Dr. Camilleri was involved in designing the study, but because Mayo Clinic physicians and scientists participated in the development and preclinical testing of the device, the initial clinical research was conducted elsewhere to avoid having results affected by a conflict of interest. The participating centers for the initial study were Flinders Medical Centre, Adelaide, Australia; Instituto National de la Nutricion (INNSZ), Mexico City; and St. Olav's University Hospital, Trondheim, Norway. James Toouli, M.D., Ph.D., of Flinders, is the co-lead author with Dr. Camilleri of the study findings published in Surgery.

Dr. Camilleri says a follow-up double-blinded study, which will involve up to 300 patients at multiple medical centers including a limited number from Mayo Clinic, will be important for gauging the device's true effectiveness.

"In an open label study such as the one being published this month, there is always potential for the device to 'work' because patients believe it
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SOURCE Mayo Clinic
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