A Novel Implant for the Treatment of Obesity

Abstract

Purpose: Obesity and its medical complications are at epidemic proportions and affect almost 60 million Americans. Because of poor compliance, treatment of obesity with dietary, behavioral or pharmacologic therapies has yielded disappointing results. Surgical approaches to obesity may be associated with significant morbidity and even mortality. As an endoscopic treatment of obesity, we have developed a temporary, transpyloric implant that would reduce the rate of gastric emptying and facilitate weight loss. In this study, we evaluated the safety of this novel endoscopically-delivered and removable implant in a porcine model. Methods: Eighteen adult Yucatan pigs initially weighing between 50–60 kg underwent endoscopic insertion of two different implants intended to result in two distinct degrees of pyloric obstruction (n = 7 each) or a sham procedure (n = 4). Specific endpoints included successful implant placement across the pylorus, symptomatic tolerance, lack of distal implant migration, and a lack of endoscopic or histopathologic ulceration, fibrosis, or pyloric stenosis. Efficacy was assessed by weekly pig weights. Fluoroscopic images were obtained at 1 week, 1 month, and 2 months post-implantation to verify device location. Endoscopic evaluation for evidence of gastroduodenal injury was performed at 3 months. Four pigs from each group will be euthanized at 6 months and full histopathology of the gastroduodenal region will be performed (these results will be available at the meeting). Two pigs from each device group will be survived an additional 3 months post device removal to evaluate potential latent implant effects. Results: Endoscopic transpyloric implant delivery was successful over a guide wire in all cases. Mean procedure time was 24 minutes. All implants have been seen to be transpyloric in at least one followup fluoroscopic image. With the exception of a single pig that regurgitated the device, all pigs have remained asymptomatic. No instances of device migration distally into the duodenum have been observed. Conclusions: Based on our initial experience, this novel implant appears to be easily delivered, tolerable, and safe in a porcine model. Additional porcine efficacy studies and human tolerance and efficacy trials are planned.