Apr. 29, 2004 CHICAGO – Northwestern Memorial Hospital is one of only eight sites nationally and the only in Chicago to participate in a research study to evaluate the safety and effectiveness of the Implantable Gastric Stimulation (IGS) – a "pacemaker" for the stomach that may create a sense of fullness. The IGS, which essentially looks and operates very similar to a typical cardiac pacemaker, will be tested to see if it is a safer, less invasive alternative to other surgical treatments for weight loss.
Manufactured by Transneuronix, this system consists of an electrical pulse generator, about the size of a pocket watch, which is placed under the skin in the abdomen and connected to the wall of the stomach with two wires. The pulse generator delivers electrical stimulation to the stomach, causing the feeling of fullness. Implanting it takes less than an hour and is done as an outpatient laparoscopic procedure.
"Surgeons are still unsure exactly why it lessens the appetite," explains Robert Kushner, M.D., medical director of the Wellness Institute at Northwestern Memorial Hospital and professor of medicine at Northwestern University’s Feinberg School of Medicine. "Possible mechanisms of action include an impact on the nerves, changes in digestive hormones or direct stimulation of stomach muscles."
Clinical data have been collected on about 450 subjects worldwide. "The IGS system, unlike most operations that treat obesity, does not alter gastrointestinal anatomy and is being tested to see if it is less invasive and results in fewer complications compared to other surgical procedures," adds Jay B. Prystowsky, M.D., chief of the Division of Gastrointestinal and Endocrine Surgery at Northwestern Memorial Hospital and professor of surgery at Northwestern University’s Feinberg School of Medicine.
The electronic pulse generator is operated by a programmer – or hand-held computer – that uses radio waves and programming software to communicate with the implanted study device from outside the body, like a remote control. The programmer can change the type of electrical signals delivered to the stomach.
Once implanted in study participants, the study device will be tested using the programmer and then immediately turned off. Fourteen days after the operation, participants will blindly be randomized into one of two groups: those who have the device turned on and those who do not.
"This device is not intended to be used at the exclusion of well-guided lifestyle changes," said Julie Roth, M.D., a physician with the Northwestern Memorial Wellness Institute and associate professor of medicine at Northwestern University’s Feinberg School of Medicine. "All participants will also work closely with physicians and dietitians at the Wellness Institute."
One year will mark the conclusion of the first part of this research study and all participants will have the device turned on. Then, researchers will begin the second part of their research, which seeks to determine if the device is safe and effective for use over an extended period of time. "We are facing a worldwide epidemic of obesity," adds Dr. Roth. "More than one billion people are affected by obesity worldwide, and at least 300 million are clinically obese – a key risk factor in type II diabetes, cardiovascular disease, high blood pressure and stroke, as well as a variety of cancers."
"It is extremely difficult for some people to lose weight and sustain their weight loss. This device might be an option for patients who have repeatedly tried to lose weight and failed," said Dr. Kushner.
Doctors hope to enroll approximately 200 participants nationally and Northwestern Memorial is recruiting approximately 30 participants.
Participants may be are eligible for this study if they meet the following requirements:
* 18 – 65 years old
* BMI of 35 to 55
* Documented history of five years of obesity with a failure to achieve and maintain weight loss with non surgical weight control
Interested participants should contact Northwestern Memorial Hospital at 312-926-8400 or visit http://www.candidatescreenings.com/SSSPWelcome.asp.
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