Laser Tissue Welding compared to Radio frequency ablation for surgical treatment

描述（由申请人提供）：长期目标Laser Tissue Welding，Inc. (LTW)该公司的研究和产品开发集中在创新的无缝激光组织焊接领域，使用可生物降解和生物相容的生物材料连接，修复和密封组织，以控制各种液体的泄漏，包括血液，胃肠液，尿液，胆汁，淋巴液，甚至脑脊液。当用于涉及创伤、癌症和移植的实体内脏器官（如肝脏、脾脏和肾脏）表面时，在存在稀释性凝血病或治疗性抗凝的情况下，不依赖于凝血因子，可挽救生命。在第一阶段SBIR下，已经完成了概念验证体内急性和慢性动物研究2，23以及原型生物材料制造，并确认了无菌性、毒性/生物相容性和有效期。下一步是进行临床安全性和有效性研究，以支持FDA提交。具体目标一。比较激光组织焊接与射频消融手术治疗肝脏肿瘤的临床安全性和有效性研究20名患者将接受激光组织焊接治疗，20名随机对照患者将接受开放射频消融（深部组织凝固）治疗原发性和转移性肝脏恶性肿瘤。本研究的目的是获得激光组织焊接治疗在人类受试者中的临床安全性和有效性特征。I A.将通过对不良事件的频率制表来评估安全性，如继发性出血和血肿导致的术后发病率;继发性感染和腹腔内脓肿;长期胆漏;肝功能受损、败血症和死亡率。I B.将通过比较治疗组和对照组的客观缓解率来确定疗效，客观缓解率基于实现完全止血的患者数量、每平方厘米覆盖面积的止血时间、术中和术后失血量（每天和天数，血液制品输血使用（术中和术后），术后胆漏（每天和天数）;手术室总时间、ICU住院时间、住院时间和住院费用。时间：24个月潜在的技术创新LTW开发了一种工艺和两种专有的生物可吸收人血白蛋白产品的组合，用于在肝脏和肾脏的手术修复期间密封组织以阻止液体泄漏（血液，胆汁和尿液）。1，2，23这种组合器械具有激光精度和多功能性，可密封组织，而无需对正常或异常组织进行热消融。在完成FDA 510（k）上市批准和特殊控制（安全性和有效性临床研究）后，我们将启动规模化生产，开展营销和商业化活动。潜在的商业应用LTW可用于密封组织，以控制各种流体的泄漏，包括血液、胃肠液、尿液、胆汁、淋巴液甚至脑脊液。常见的包括创伤修复和肝脏止血（27，000例患者/年）;肝脏肿瘤：原发性肝癌（105，000例/患者/年）和转移性肝肿瘤（595，000例患者/年）;能够常规进行劈离式肝移植或使供体器官库加倍（27，876例/年）;良性病变肾部分切除术（500例/年）;尿道修复术：用于尿道下裂、尿道狭窄、尿道憩室和尿道瘘（600/年）以及皮肤/真皮缝合和目前使用缝线的所有外科手术。

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.