Over 1.5 million Americans suffer from clinically severe obesity, a serious health problem. Surgical intervention is the only proven effective, long-term therapy for most of these individuals. Current surgical procedures restrict food intake or reduce absorption by cutting, stapling, and/or bypassing portions of the gastrointestinal tract. These procedures have a perioperative complication rate of over 10 percent and sometimes fail due to problems with stoma size. The goal of the study is to provide a safer, more adjustable, yet effective surgical option. This project is a clinical trial designed to evaluate the safety and effectiveness of an ASGB System for use in the surgical treatment of severe obesity. The system includes a calibration tube connected to an electronic sensor for precise pouch and stoma sizing during band placement. The reinforced silicone gastric band is placed surgically around the stomach to create the gastric pouch and stoma, and no staples or anastomoses are required. The band has an inflatable section connected via tubing to an injection port that can be accessed percutaneously, permitting stoma size adjustment postoperatively, without reoperation. Early data are promising, with perioperative complication rate of 3.4 percent and two-year excess weight loss of 62.5 percent. During Phase I, clinical trials will begin at three sites. Forty severely obese patients will have the ASGB surgically implanted and will be followed for perioperative complications and early weight loss. In Phase II, the number of subjects will be increased. Weight loss, late complications and recidivism over two years will be investigated.
