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: 8011181
• 负责人: YASMIN WADIA
• 金额: $ 43.06万
• 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 2012-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8011181
• 关键词: Abdominal Abscess; Acute; Address; Adverse event; Albumins; Animals; Anticoagulation; Area; Argon; Benign; Bile fluid; Biliary; Biocompatible; Biocompatible Materials; Blood; Blood Coagulation Disorders; Blood Coagulation Factor; 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; repaired; research and development; 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（由申请人提供）： 长期目标 Laser Tissue Welding, Inc. (LTW) 将其研究和产品开发重点放在创新无缝激光组织焊接领域，使用可生物降解和生物相容性生物材料来连接、修复和密封组织，以控制各种液体的渗漏，包括血液、胃肠液、尿液、胆汁、淋巴液甚至 脑脊液。当用于实体内脏器官（例如肝、脾和肾）的表面时，它可以挽救生命，这些器官涉及创伤、癌症和移植，与凝血因子无关，并且存在稀释性凝血病或治疗性抗凝。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以及无菌、毒性/生物相容性和保质期验证已在第一阶段 SBIR 下完成。下一步是进行临床安全性和有效性研究以支持 FDA 的提交。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 名随机对照将接受开放式射频消融（深部组织凝固）治疗，以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疗法在人类受试者中的临床安全性和有效性概况。 I A. 将通过列出不良事件的频率来评估安全性，例如继发性出血和血肿引起的术后发病率；继发感染和腹内脓肿；长期胆漏；肝功能受损、败血症和死亡。 I B. 疗效将通过比较治疗和对照的客观缓解率来确定，该缓解率基于实现完全止血的患者数量、每平方厘米面积的止血时间、术中和术后失血量（每天和天数、血液制品输注使用量（术中和术后）、术后胆漏（每天和天数）；总手术室时间、ICU 停留时间、住院时间和 医院费用。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生物可吸收人白蛋白产品的组合，用于在肝脏和肾脏的手术修复过程中密封组织以阻止液体渗漏（血液、胆汁和尿液）。1,2,23 这种组合设备具有激光精度和多功能性，可以密封组织，而无需热消融正常或异常组织。 预期成果 在通过特殊控制（安全性和有效性临床研究）完成 FDA 510 (k) 市场批准后，我们将启动扩大生产规模，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，以控制多种液体的渗漏，包括血液、胃肠液、尿液、胆汁、淋巴液，甚至脑脊液。常见的群体包括创伤 肝脏修复和止血（27,000 人/年）；肝脏肿瘤：原发性肝癌（105,000 例/年）和转移性肝肿瘤（595,000 例/年）；实现常规分割肝移植或使供体器官库增加一倍（27,876 例/年）；良性病变肾部分切除术（500/年）； 尿道修复：用于尿道下裂、尿道狭窄、尿道憩室和尿道瘘（600/年）和皮肤/真皮接近以及目前使用缝合的所有外科手术。