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: 10383794
• 负责人: Daniel Francis
• 金额: $ 156.95万
• 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/10383794
• 关键词: Abdomen; Accidental Injury; African American population; Anatomy; Animal Model; Award; Benign; Biological; Cadaver; Cancerous; Caucasians; Clinical Research; Colectomy; Communities; Complication; Containment; Device Removal; Devices; 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 complication; Surgical incisions; System; Techniques; Testing; Time; Tissues; Training; United States; United States National Institutes of Health; Uterine myomectomy; Uterus; Vagina; Validation; Woman; base; biomaterial compatibility; cancer cell; cancer risk; 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; refractory cancer; 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.

摘要 在美国，每年大约有500,000例子宫切除术，通常是为了子宫 肌瘤引起的肿大。2014年，FDA提供了针对不受限制的腹腔镜动力的指导 粉碎，微创过程中快速取出大样本(如子宫)的一种方法 做手术。FDA确定，电动粉碎机增加了接受手术的女性癌症扩散的风险 妇科良性肌瘤的腹腔镜手术治疗。预防隐性癌症的扩散 微创手术在许多手术中都是一个未解决的需求，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的指导方针离开了妇科 没有强大工具的外科医生能以最小的侵入性切除大子宫。中开发的主要技术 对指导的反应，称为包含手动粉碎，是一种标签外技术，需要将 将子宫放在容器中，用手术刀取出，然后通过腹部或腹部的切口处抓取 阴道。这项技术很慢(通常需要10-30个手术刀刀片，需要20-40分钟)，而且效果不佳 含有癌细胞(8%-41%有记录的容器泄漏)。另一种选择是开放手术，费用很高。 (约2.75晚住院)，相关发病率/死亡率高(1：5000死亡率，1：20严重 并发症)。 克拉里亚医疗公司正在开发一种组织遏制和提取系统(TCES)，该系统将使安全， 快速、经济、微创摘除大子宫。手术速度和安全性的提高 Claria TCES使手术能够在当天的门诊形式下进行，避免了开放 手术、并发症和长时间住院。这一第二阶段提案的关键里程碑是提交 TCES向FDA申请510(K)批准。目标1侧重于几个设计的设计优化和执行 验证和确认协议包括：生物屏障测试、电气安全测试、生物兼容性 按照FDA的要求进行测试、灭菌和保质期测试。目标2是一项形成性可用性研究，有四个 外科医生，并开发了手术模拟器和动物的外科培训方案和验证计划 模特。目标3是对34名外科医生进行的总结性评估，以验证培训方案和 无辅助模拟子宫摘除手术中的Claria Tce。在FDA 510(K)批准后，~1.5- 在为这项建议提供资金2年后，Claria将进行额外的上市后临床评估，a 在良性和恶性组织切除的其他适应症方面的商业推出和临床研究。