A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery

用于腹腔镜子宫切除术和其他微创手术中组织切除的安全、快速且经济有效的系统

• 批准号: 10693810
• 负责人: Daniel Francis
• 金额: $ 14.19万
• 依托单位: CLARIA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10693810
• 关键词: Abdomen; Accidental Injury; Accidents; African American population; Anatomy; Animal Model; Award; Benign; Biological; Cadaver; Cancerous; Caucasians; Clinical Research; Colectomy; Communities; Complication; Containment; Device Removal; Devices; Electric Conductivity; Equity; Evaluation; Excision; Fibroid Tumor; Funding; Future; Gynecologic; Gynecologic Surgical Procedures; Hospitals; Hour; Human; Hysterectomy; Instruction; Label; Left; Legal patent; Length of Stay; Life; Malignant - descriptor; Malignant Neoplasms; Manuals; Marketing; Mechanics; Medical; Methods; Mexico; Morbidity - disease rate; Nephrectomy; Operative Surgical Procedures; Outpatients; Ovariectomy; Pain; Patients; Phase; Physicians; Procedures; Protocols documentation; Publications; Ramp; Readiness; Recommendation; Reporting; Resistance; Risk; Safety; Sales; Savings; Series; Specimen; Speed; Splenectomy; Stainless Steel; Sterilization; Surgeon; Surgical incisions; System; Techniques; Testing; Time; Tissues; Training; United States; United States National Institutes of Health; Uterine myomectomy; Uterus; Vagina; Validation; Woman; barrier to testing; biomaterial compatibility; cancer cell; cancer risk; commercial launch; cost; cost effective; design; design verification; disparities in morbidity; experience; flexibility; improved; innovation; meetings; minimally invasive; mortality; post-market; prevent; profiles in patients; programs; racial disparity; rapid technique; research clinical testing; response; safety testing; scalpel; tool; usability; validation studies; verification and validation

Abstract In the United States approximately 500,000 hysterectomies are performed per year, typically for uterine enlargement as a result of fibroids. In 2014 the FDA provided guidance against uncontained laparoscopic power morcellation, a method of rapidly removing a large specimen (such as the uterus) during minimally invasive surgery. The FDA determined that power morcellators increased risk of cancer spread in women undergoing laparoscopic gynecologic surgery for presumed benign fibroids. Preventing the spread of hidden cancers during minimally invasive surgery is an unaddressed need across many procedures, including: hysterectomy, myomectomy, colectomy, oophorectomy, splenectomy, and nephrectomy. The FDA guidance left gynecologic surgeons without great tools for removing large uteri minimally invasively. The primary technique developed in response to the guidance, called contained manual morcellation, is an off-label technique which requires putting the uterus in a container and extracting it with a scalpel and graspers through an incision in the abdomen or out the vagina. The technique is slow (often requires 10-30 scalpel blades and takes 20-40 minutes), and ineffective at containing cancer cells (8-41% documented container breaches). Another alternative, open surgery, is costly (~2.75 nights in the hospital) and has high associated morbidity / mortality (1:5000 mortality, 1:20 serious complications). Claria Medical is developing a Tissue Containment and Extraction System (TCES) which will enable the safe, rapid and cost-effective removal of large uteri minimally invasively. The improved surgical speed and safety that the Claria TCES provides enables surgeries to be performed in a same-day outpatient format avoiding open surgery, complications, and long hospital stays. The key milestone of this Phase II proposal is to submit the TCES to the FDA for 510(k) clearance. Aim 1 focuses on design optimization and execution of several design verification and validation protocols including: biological barrier testing, electrical safety testing, biocompatibility testing, sterilization and shelf life testing as required by the FDA. Aim 2 is a formative usability study with four surgeons and develops a surgical training protocol and validation program with surgical simulators and an animal model. Aim 3 is a summative evaluation with 34 surgeons validating the training protocol and usability of the Claria TCES during unassisted simulated uterine extraction surgery. Subsequent to FDA 510(k) clearance, ~1.5- 2 years after funding of this proposal, Claria will perform an additional post-market clinical evaluation, a commercial launch, and clinical studies in additional indications for benign and malignant tissue removal.

抽象的 在美国，每年进行大约500,000个子宫切除术，通常用于子宫 肌瘤的结果。 2014年，FDA提供了针对无腹腔镜功率的指导 Morcellation，一种在微创时迅速去除大型标本（例如子宫）的方法 外科手术。 FDA确定功率旋转器增加了正在接受的妇女的癌症传播风险 假定良性肌瘤的腹腔镜妇科手术。防止隐藏癌症在 在许多手术中，微创手术是一项尚未解决的需求，包括：子宫切除术， 肌瘤切除术，结肠切除术，卵巢切除术，脾切除术和肾切除术。 FDA指导留下了妇科 外科医生没有出色的工具，可以微创地去除大型子宫。主要技术在 对指导的响应，称为手动变形，是一种标签的技术，需要放置 子宫在容器中，并用手术刀将其提取，然后通过腹部切口抓握 阴道。该技术很慢（通常需要10-30个手术刀叶片，需要20-40分钟），无效 在含有癌细胞时（8-41％的记录了容器破裂）。另一个替代手术是昂贵的 （医院〜2.75晚），并且具有高关联的发病率 /死亡率（1：5000死亡率，1:20严重 并发症）。 Claria Medical正在开发组织遏制和提取系统（TCE），该系统将使安全， 快速且具有成本效益的大子宫的侵入性去除。改善的手术速度和安全性 Claria TCE提供了使手术以同一天的门诊格式进行的手术，避免打开 手术，并发症和长期住院。该第二阶段提案的关键里程碑是提交 TCES到FDA进行510（k）清除率。 AIM 1专注于设计优化和执行几种设计 验证和验证方案包括：生物屏障测试，电气安全测试，生物相容性 根据FDA的要求进行测试，灭菌和保质期测试。 AIM 2是一项具有四个的形成性可用性研究 外科医生并通过手术模拟器和动物制定了手术培训方案和验证计划 模型。 AIM 3是34位外科医生验证培训方案和可用性的总结性评估 在未辅助的模拟子宫提取手术期间，Claria TCE。在FDA 510（k）间隙之后，〜1.5- 在此提案资助后2年，Claria将进行额外的市场后临床评估， 商业发射和临床研究，促进了良性和恶性组织清除的其他指示。