A biodegradable barrier preventing anastomotic leaks after esophagectomy

Project Summary/Abstract This SBIR Phase I application will demonstrate feasibility of LeakGuard by: 1) assessing the mechanical and degradation properties of LeakGuard in esophageal-like conditions and 2) demonstrating LeakGuard’s ability to protect from anastomotic leakage after esophageal resection in the porcine model. Esophageal cancer affects over 50,000 Americans each year. The gold-standard treatment is esophageal resection, but up to 22% of patients develop a complication called anastomotic leakage (AL), resulting in high morbidity and mortality. Current treatments, such as stents and endoscopic vacuum therapy, do not prevent AL and still often result in high patient morbidity and mortality, as well as extended time spent in the hospital. Existing preventative solutions, such as omentoplasty, are surgical based and cannot be performed on every patient and have the potential to result in very serious complications. Therefore, an unmet need exists for an effective method to prevent AL that can be used on any patient, reducing the morbidity and mortality of esophagectomy. SafeGuard Surgical has developed LeakGuard, a biodegradable barrier device that is prophylactically placed within the esophageal lumen during esophagectomy. It covers and protects the esophagogastric anastomotic site enabling esophageal healing, while concurrently preventing anastomotic leakage. The biodegradability of LeakGuard allows for it to be administered during the esophagectomy, eliminating the need for a second surgery. To determine the feasibility of the device, the mechanical and degradation proprieties of LeakGuard will be assessed at pH within the esophageal lumen (4.0 and 7.0). The tensile strength, burst pressure, and fluid permeability will be determined. The ability of the LeakGuard to protect from AL in vivo will be evaluated in a pig model. Pigs will undergo an esophagectomy, and a simulated leak will be created and LeakGuard administered. Pigs will be sacrificed at 7 days, 14 days, and 28 days to evaluate healing and the degree of leak protection. Successful completion of this project will validate that LeakGuard can be used to protect from anastomotic leakage post-esophagectomy.