Laser Tissue Welding compared to Radio frequency ablation for surgical treatment

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): Long term objectives Laser Tissue Welding, Inc. (LTW) focuses its research and product development in areas of innovative sutureless laser tissue welding using biodegradable and biocompatible biomaterials to join, repair and seal tissues for controlling the leakage of a wide variety of fluids including blood, gastrointestinal fluids, urine, bile, lymph, and even cerebrospinal fluids. It is life saving when used on the surfaces of solid visceral organs, such as the liver spleen and kidney, involved in trauma, cancer and transplantation independent of coagulation factors and in presence of dilution coagulopathies or therapeutic anticoagulation. Proofs-of- concept in-vivo acute and chronic animal studies2, 23 and prototype biomaterial manufacture with validation of sterility, toxicity/biocompatibility and shelf-life have been completed under phase I SBIR. The next step is to conduct clinical safety and efficacy studies to support the FDA submission. Specific Aims I. Laser Tissue Welding compared to Radiofrequency ablation for surgical treatment of liver neoplasms A Clinical Safety and Efficacy Study Twenty patients will be treated with laser tissue welding and 20 randomized controls will be treated with open radiofrequency ablation (deep tissue coagulation) for treatment of primary and metastatic liver malignancies. The objective of this study will be to obtain a clinical safety and efficacy profile about laser tissue welding therapy in human subjects. I A. Safety will be assessed by tabulating the frequency of adverse events, such as postoperative morbidity due to secondary hemorrhage and hematoma; secondary infection and intra-abdominal abscess; prolonged biliary leak; compromised liver function, septicemia and mortality. I B. Efficacy will be determined by comparing treatment and controls with respect to the objective response rate based on the number of patients who achieve complete hemostasis, the time to hemostasis per cm2 area covered, intraoperative and postoperative blood loss (per day and number of days, blood product transfusion use (intraoperative and postoperative), postoperative bile leakage (per day and number of days); total operating room time, ICU stay, hospital stay and hospital costs. Time: 24 months Potential Technology innovation LTW has developed a combination of a process and two proprietary bioabsorbable human albumin products that are applied to seal tissues to stop fluid leaks (blood, bile and urine), during surgical repair of the liver and kidney.1, 2, 23 This combination device has laser precision with the versatility to seal tissues without thermal ablation of normal or abnormal tissues. Anticipated Outcomes After completion of FDA 510 (k) market approval with special controls (safety and efficacy clinical study) we will launch scaled-up manufacturing, undertake marketing and commercializing activities. Potential commercial applications LTW can be used to seal tissues for controlling the leakage of a wide variety of fluids including blood, gastrointestinal fluids, urine, bile, lymph, and even cerebrospinal fluids. Common groups include trauma repair and hemostasis of the liver (27,000 pts/yr); liver tumors: primary hepatomas (105,000/pts/yr), and metastatic liver tumors (595,000pts/yr); enable split liver transplants routinely or doubling donor organ pool (27,876pts/yr); partial nephrectomy for benign lesions (500/yr); urethral repair: for hypospadias, urethral stricture, urethral diverticulum, and urethral fistulae (600/yr) and skin/dermal approximation and all surgical procedures that currently use sutures.