Laser Tissue Welding compared to Radio frequency ablation for surgical treatment

激光组织焊接与射频消融手术治疗的比较

• 批准号: 7802395
• 负责人: YASMIN WADIA
• 金额: $ 71.51万
• 依托单位: LASER TISSUE WELDING, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-01 至 2011-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7802395
• 关键词: Abdominal Abscess; Acute; Address; Adverse event; Albumins; Animals; Anticoagulation; Area; Argon; Benign; Bile fluid; Biliary; Biocompatible; Biocompatible Materials; Blood; Blood Clot; Blood Coagulation Disorders; Blood Coagulation Factor; Blood coagulation; Burn injury; Cerebrospinal Fluid; Chronic; Clinical; Clinical Research; Clinical Trials; Coagulation Process; Data; Dermal; Devices; Diagnosis; Diathermy; Drug resistance; Evaluation; Excision; Extravasation; Failure; Fistula; Frequencies; Goals; Government; Grant; Head; Healed; Hematoma; Hemorrhage; Hemostatic function; Hospital Costs; Human; Hypospadias; In Vitro; Kidney; Lasers; Length of Stay; Lesion; Life; Liquid substance; Liver; Liver neoplasms; Lymph; Malignant Neoplasms; Marketing; Mediating; Medical; Methods; Morbidity - disease rate; Necrosis; Nephrectomy; Normal tissue morphology; Operating Rooms; Operative Surgical Procedures; Optics; Organ; Organ Donor; Outcome; Patients; Persons; Phase; Postoperative Hemorrhage; Postoperative Period; Primary carcinoma of the liver cells; Process; Pseudomonas aeruginosa; Radiofrequency Interstitial Ablation; Randomized; Research; Robotics; Safety; Secondary to; Septicemia; Skin; Small Business Innovation Research Grant; Solid; Spleen; Sterility; Streptococcus pyogenes; Surface; Surgeon; Surgical sutures; Technology; Therapeutic; Therapeutic Effect; Thermal Ablation Therapy; Time; Time Study; Tissues; Toxic effect; Transfusion; Trauma; Urethra; Urethral Diverticulum; Urethral Stricture; Urine; Validation; Vascular blood supply; Visceral; Welding; Wound Healing; base; biomaterial compatibility; blood product; cancer transplantation; commercial application; follow-up; gastrointestinal; healing; human subject; in vivo; innovation; liver function; liver transplantation; manufacturing scale-up; methicillin resistant Staphylococcus aureus; minimally invasive; mortality; pressure; prevent; product development; prototype; public health relevance; repaired; response; restoration; scaffold; seal; secondary infection; success; tissue trauma; tissue welding; trial comparing; tumor

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.

描述(申请人提供)：长期目标激光组织焊接公司(LTW)专注于创新的无缝合激光组织焊接领域的研究和产品开发，使用可生物降解和生物兼容的生物材料连接、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，甚至脑脊液。用于肝、脾、肾等实体内脏器官表面，涉及创伤、癌症和移植，不依赖凝血因子，在存在稀释凝血疾病或治疗性抗凝的情况下，可挽救生命。在第一阶段SBIR下，已经完成了体内急性和慢性动物研究2、23和原型生物材料的概念验证，并对无菌、毒性/生物兼容性和保质期进行了验证。下一步是进行临床安全性和有效性研究，以支持FDA提交的文件。具体目标I.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式射频消融(深层组织凝固)治疗原发和转移性肝脏恶性肿瘤。这项研究的目的将是获得激光组织焊接治疗在人体中的临床安全性和有效性。将通过列出不良事件的频率来评估安全性，例如术后因继发性出血和血肿引起的发病率；继发感染和腹内脓肿；长期胆漏；肝功能受损、败血症和死亡率。通过比较治疗和对照组的客观有效率来确定疗效，这些客观有效率的基础是：完全止血的患者数量、每平方厘米面积止血的时间、术中和术后失血(每天和术后天数)、输血(术中和术后)使用、术后胆漏(每天和天数)、总手术室时间、ICU住院时间、住院时间和住院费用。时间：24个月潜在技术创新LTW开发了一种工艺和两种专有的可生物吸收的人体白蛋白产品的组合，应用于密封组织，以阻止肝脏和肾脏手术修复期间的液体泄漏(血液、胆汁和尿液)1、2、23这种组合设备具有激光精度，具有多功能，可以密封组织，而不会对正常或异常组织进行热消融。预期结果FDA 510(K)上市审批和特殊控制(安全性和有效性临床研究)完成后，我们将启动大规模生产，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，以控制各种液体的泄漏，包括血液、胃肠道液体、尿液、胆汁、淋巴，甚至脑脊液。常见的组包括创伤修复和肝脏止血(27,000例次/年)；肝肿瘤：原发性肝癌(105,000例次/年)和转移性肝肿瘤(595,000例次/年)；使分离式肝移植成为常规手术或使供体器官池增加一倍(27,876例次/年)；良性病变的肾部分切除术(500例次/年)；尿路修复：用于尿道下裂、尿路狭窄、尿路憩室和尿瘘(600例次/年)以及皮肤/真皮近似术和所有目前使用缝线的外科手术。