NewYork-Presbyterian Is Only NYC-Area Center To Study Implantable Device for Obese Individuals; Study Participants Now Being Recruited
Jul 21, 2004
A new clinical research study is investigating the use of an implantable stomach stimulator device the Transneuronix Transcend® Implantable Gastric Stimulation (IGS®) System which uses a low-current electrical pulse to trick the body into feeling full in order to achieve and maintain weight loss. Obese individuals are now being recruited for the two-year national multi-center study at centers including NewYork-Presbyterian Hospital/Columbia University Medical Center the only New York City-area study site.
The new study aims to confirm earlier research on the IGS System, finding that patients using the system lose and maintain more weight than the control group, with minimal complications. For the duration of the study, physicians will closely monitor participants' weight loss, satiety, appetite, and several other medical measures.
The IGS System has been shown to be a safe, reversible procedure, with no permanent changes to the gastrointestinal tract. And unlike diet drugs or dieting, the IGS System has not only facilitated weight loss, but has helped keep the weight off, dramatically improving the long-term health of those using the stimulator, says Dr. Marc Bessler, principal investigator at the NewYork-Presbyterian Hospital/Columbia study site, assistant attending surgeon at NewYork-Presbyterian Hospital, and assistant professor of surgery at Columbia University College of Physicians Surgeons.
Clinical studies have suggested that a sustained weight loss of five percent of body weight can reduce or eliminate obesity-related disorders, such as diabetes, coronary artery disease, Type 2-diabetes, and hypertension, says Dr. Louis Aronne, a co-principal investigator of the study, attending physician at NewYork-Presbyterian Hospital and adjunct clinical professor of medicine at Columbia University College of Physicians Surgeons. According to a 2001 study of the IGS System, patients using the device lost an average of 30 percent of their excess weight after three years. Dr. Aronne is also clinical professor of medicine at Weill Cornell Medical College.
As part of the new study, the IGS System will be implanted under the patient's abdominal skin during a minimally invasive laparoscopic procedure that takes less than an hour. Half of the study group will be randomly assigned to receive gastric stimulation, and half to a control group (no stimulation). Both groups will participate in a calorie-restrictive diet and monthly support group meetings. After implantation, a programmer will use a handheld computer (the Transender™ Programming System), to choose the level of charge that will maximize potential weight loss; these settings can be readjusted later. When it is active, IGS System's miniature generator delivers an electric pulse through two lead wires, which conduct the energy into the smooth muscle of the stomach. The stimulator's maximum charge is 8.5 volts, comparable to a 9-volt transistor radio battery.
In the second year of the study, all patients will receive gastric electrical stimulation, and the long-term efficacy and safety and maintenance of weight loss will be evaluated. After two years, all patients will have the option to enter an extension study for an additional four years, during which time the long-term efficacy and safety and maintenance of weight loss will continue to be evaluated.
NewYork-Presbyterian Hospital is currently recruiting obese and morbidly obese men and women between the ages of 18 and 65 with a body mass index (BMI) between 35 and 55. Ineligible patients include those who have undergone previous surgery of the gastrointestinal tract for obesity, or surgery of any kind on the stomach; those who already have another implanted electrostimulation device; those taking weight-loss medication or other drugs that affect body weight; and pregnant or lactating women. Study participants must complete a Binge Eating Questionnaire and psychological evaluation as part of the screening process. A maximum of 30 patients will be enrolled at each of the study centers.
Unlike previous research, the current study patients are screened based on a Transneuronix-designed screening algorithm that uses age, gender, body weight, BMI, and responses to a quality-of-life questionnaire. The algorithm has shown to predict which patients will do well with this device and thus only patients who pass this screening will be eligible to participate. Additionally, the new study adds more extensive nutritional counseling, including a calorie-restrictive diet.
The IGS System is based on research done by Dr. Valerio Cigaina at Umberto I Hospital in Venezia-Mestre, Italy. The first gastric stimulator for the treatment of morbid obesity was implanted by Dr. Cigaina in 1995. To date, over 300 patients have been implanted with the IGS System at more than 40 study sites throughout the world.
Recent results from the 1999-2000 National Health and Nutrition Examination Survey (NHANES) indicate that an estimated 64 percent of U.S. adults are either overweight or obese, defined as having a BMI of 25 or higher. Among adults age 20 to 74 years, the estimated prevalence of obesity (BMI greater than or equal to 30.0) has doubled between 1980 and 2000, from approximately 15 percent to an estimated 31 percent. Factors responsible for the rapid increase in excess weight are not fully understood, but may include increased sedentary lifestyle and the prevalence of fast food.
Obesity is the second leading cause of preventable death, exceeded only by cigarette smoking. Obesity is also associated with complications of pregnancy, menstrual irregularities, hirsutism, stress incontinence, and psychological disorders such as depression.
The study's principal investigator is Dr. Scott Shikora of Tufts-New England Medical Center (Boston, MA).
The Transneuronix Transcend® Implantable Gastric Stimulation (IGS®) system consists of the Transcend II Implantable Gastric Stimulator (IGS), Model 8848 Transender™ Programming System, Model 8898 Software Application Card, and two Transcend Model 9107 Gastric Stimulation Leads. Transneuronix, Inc. is based in Mount Arlington, NJ.