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.

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脑脊液。当在固体内脏器官（例如肝脏脾脏和肾脏）的表面上使用时，它可以节省生命，这些肝脏和肾脏涉及创伤，癌症和移植，独立于凝结因子以及稀释性凝血症或治疗性抗凝性。在I阶段SBIR下，已经完成了体内急性和慢性动物研究2、23和慢性动物研究2、23和原型生物材料制造。下一步是进行临床安全和功效研究以支持FDA提交。具体目的I.激光组织焊接与肝脏肿瘤的射频消融相比，临床安全性和功效研究将用激光组织焊接治疗二十名患者，将使用20种随机对照组进行治疗，并通过开放的放射性消融（深层组织凝结）治疗原发性和耐元症。这项研究的目的是获得有关人类受试者激光组织焊接疗法的临床安全性和功效。 I A.安全将通过制定不良事件的频率来评估安全性，例如由于继发性出血和血肿引起的术后发病率；继发感染和腹腔内脓肿；长时间的胆道泄漏；肝功能，败血病和死亡率受损。 I B.功效将通过比较治疗和对照对客观反应率的对照来确定，该患者的数量基于达到完全止血的患者数量，涵盖CM2面积止血的时间，术中和术后失血（每天和日常的日常数，血液产物输血的使用情况）（术中和术后），术中和室内漏气时间（每天泄漏）（每天均为日常生活）（每天均为日常数量，每天），每天;医院费用：24个月的潜在技术创新LTW在过程中发展了一个过程和两个专有的生物吸附的人白蛋白产品，这些产品可用于密封组织，以阻止液体泄漏（血液，胆汁和尿液），在肝脏和肾脏的手术修复过程中FDA 510（k）市场批准完成后的预期结果（安全和功效临床研究），我们将启动扩大的制造，进行营销和商业化活动。潜在的商业应用LTW可用于密封组织，以控制多种流体的泄漏，包括血液，胃肠道液，尿液，胆汁，淋巴甚至脑脊液。普通组包括肝脏的创伤和止血（27,000分/年）；肝肿瘤：原发性肝瘤（105,000/pts/yr）和转移性肝肿瘤（595,000分/年）；常规启用分裂肝移植或加倍供体器官池（27,876分/年）；良性病变的部分肾切除术（500/年）；尿道修复：对于尿道炎，尿道狭窄，尿道憩室和尿道瘘（600/年）和皮肤/皮肤近似以及当前使用缝合线的所有手术程序。