Project Description
USA FDA, AAALAC Preclinical Contract Research Organization required for porcine bariatric models to evaluate the preclinical safety and efficacy of a novel gastric banding device. The general study outline currently under consideration consists of 10 animals (Rx vs control), 90 day in-life phase with daily clinical observations (including weight) followed by necropsy and histopathology of the treatment site. In addition, we have a trained human surgeon (MD, FACS) who specializes in bariatric surgery and is familiar with the specifics of the device, who is interested in performing the experimental laparoscopic procedure in the animals under the appropriate veterinary supervision.
Project Information
Number:09-1506