Biodegradable Sealant for Biopsy Tract in Soft Tissue

用于软组织活检道的可生物降解密封剂

• 批准号: 6934012
• 负责人: LUCJAN J J HRONOWSKI
• 金额: $ 23.35万
• 依托单位: BIOPSY SCIENCES, LLC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-21 至 2007-05-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6934012
• 关键词: adhesions; biodegradable product; biomaterial development /preparation; biomaterial evaluation; biopsy; biotechnology; clinical research; clinical trials; disease /disorder prevention /control; fine needle aspiration; human subject; lung; neoplasm /cancer diagnosis; pneumothorax disorder; polymers; postoperative complications; respiratory disorder diagnosis; surgery material /equipment; swine

DESCRIPTION (provided by applicant): Percutaneous Transthoracic Lung Biopsy using a Fine Needle Aspiration (FNA) biopsy is a common method of determining if a lung nodule is benign or malignant. Using imaging guidance {CT, fluoroscopy, ultrasound or bronchoscopy) a sharp needle is advanced into a suspicious area and cells are aspirated into the needle. These cells are then evaluated under a microscope and are characterized as benign, infectious or malignant. There are over 169,500 cases of lung cancer diagnosed in the U.S. and over 600,000 lung biopsies performed worldwide every year. The most common complication of this procedure is a lung collapse (pneumothorax), which occurs in 20-40% of cases. In greater than 10% of these lung collapses, the patient becomes symptomatic and requires chest tube placement and hospitalization. The development of a novel biopsy needle tract sealant that will reduce or eliminate pneumothorax would be most valuable. Proof of principal was achieved during Phase I with great results. Biopsy Sciences has decided to proceed with the safety clinical studies. 10 patient IDE was obtained from FDA which was concluded three months ago. Based on the result, FDA has granted us with a 510{k) approval for the Plug as a Site Marker. One of objectives for Phase II is to evaluate a modified version of the hydrogel as the base material with complete degradation of three months. However the focus of the investigation will be to complete the efficacy (pivotal) study in humans to use the plug to prevent / reduce the pneumothorax rate. These goals are discussed in detail in the specific aim section. There is presently no commercially available product in the United Stares to prevent or reduce the pneumothorax rate after lung Fine Needle Aspiration Biopsy (FNAB) Procedures.

描述（由申请人提供）： 使用细针抽吸 (FNA) 活检进行经皮经胸肺活检是确定肺结节良性或恶性的常用方法。使用成像引导（CT、透视、超声波或支气管镜检查）将锋利的针推进到可疑区域，并将细胞吸入针中。 然后在显微镜下对这些细胞进行评估，并将其鉴定为良性、感染性或恶性。 美国每年诊断出超过 169,500 例肺癌病例，全球每年进行超过 600,000 例肺活检。该手术最常见的并发症是肺塌陷（气胸），这种情况发生在 20-40% 的病例中。在超过 10% 的肺塌陷中，患者会出现症状，需要放置胸管并住院治疗。 开发一种能够减少或消除气胸的新型活检针道密封剂将是最有价值的。第一阶段完成了本金证明，取得了很好的成果。 Biopsy Sciences 已决定继续进行安全性临床研究。 10名患者的IDE是从三个月前签订的FDA获得的。根据结果​​，FDA 已授予我们 510{k) 批准，将插头用作站点标记。第二阶段的目标之一是评估作为基础材料的水凝胶的改良版本在三个月内完全降解。然而，调查的重点将是完成人类使用塞子预防/降低气胸率的功效（关键）研究。 这些目标将在具体目标部分详细讨论。目前 United Stares 尚无市售产品可预防或降低肺细针抽吸活检 (FNAB) 手术后气胸发生率。