SILICONE INTRAGASTRIC DISPLACEMENT DEVICE FOR TREATING OBESITY

THE SILICONE INTRAGASTRIC BALLOON (SIB) PROJECT IS DESIGNED TO EVALUATE THE EFFECTIVENESS OF AN ARTIFICIAL BEZOAR TO INDUCE WEIGHT LOSS IN OBESE ADULTS. OBESITY IS A MAJOR HEALTH CONCERN, AS OBESE AMERICANS HAVE AN INCREASED RISK OFHEART DISEASE, DIABETES, HYPERTENSION, AND OTHER HEALTH PROBLEMS. WEIGHT LOSS HAS POSITIVE EFFECTS BUT IS OFTEN VERY DIFFICULT. ALTERNATIVES, SUCH AS SURGERY, INVOLVE KNOWN COMPLICATIONS AND SIDE EFFECTS. THE PROJECT INVOLVES A MEDICALLY SUPERVISED, RANDOMIZED CROSSOVER CLINICAL TRIAL. OBESE ADULTS (120) WHO ARE AT LEAST 40 PERCENT OVERWEIGHT AND WHO HAVE FAILED PREVIOUS WEIGHT-LOSS PROGRAMS WILL PARTICIPATE AS OUTPATIENTS FOR 24 WEEKS AT THREE TO FOUR CENTERS. FIFTY PERCENT WILL HAVE SIBS IN PLACE FOR THE FIRST 12 WEEKS; ALL WILL HAVE SIBS DURING THE SECOND 12 WEEKS. SUBJECTS WILL BE EVALUATED FOR SAFETY, WEIGHT LOSS, AND HEALTH BENEFITS AND WILL BE FOLLOWED FOR 1 YEAR AFTER SIB REMOVAL. THE SIB INDUCED SIGNIFICANT WEIGHT LOSS IN ANIMAL AND INITIAL CLINICAL STUDIES. THE DESIGN AND MANUFACTURE OF THESIB UTILIZES TECHNOLOGICALLY SOPHISTICATED METHODS AND MATERIALS TO CREATE A DURABLE, SMOOTH, COMPLIANT, AND BIOLOGICALLY INERT STRUCTURE. THE NOMINAL VOLUME OF 500CC SALINE IS ADJUSTABLE IN SITU. THE DEFLATED DEVICE IS MINIMAL IN SIZE AND IS SOFT AND ELASTIC FOR EASE OF REMOVAL.