A Novel Full Sense Device to Treat Obesity in a Porcine Model: Preliminary Results.

ABSTRACT

PURPOSE: To evaluate the technical feasibility, safety, and efficacy of a novel full sense device (FSD) for the treatment of obesity in a porcine model. MATERIALS AND METHODS: The novel FSD comprised a self-expanding metallic esophageal stent connected to a star-shaped nitinol disk. Three types of FSD were used fully covered (type A), fully covered with barbs (type B), and uncovered with barbs (type C). Nine juvenile pigs were divided into two groups FSD (n = 6) and control (n = 3). FSD type A was placed in the FSD group. In case of migration, either FSD type B or type C was then randomly placed. Food intake was monitored daily. Weight changes and ghrelin hormone levels were monitored weekly for 12 weeks. RESULTS: FSD placement was technically successful in all pigs. All FSDs except one migrated to the stomach within 1 week after placement. The pig in which the FSD was retained showed decreased food intake in the first week after FSD placement, and there was a difference in the final weight between the FSD pig and control pigs. The percentage of weight gain was 116.6% in the control group and 105.3% in the FSD pig. CONCLUSION: FSD placement under fluoroscopic and endoscopic guidance is technically feasible and safe in a porcine model. The uncovered FSD appears to decrease food intake and reduce the rate of weight gain. However, the high FSD migration rate is not encouraging.