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，每年大约进行 500,000 例子宫切除术，通常是为了子宫切除术 由于肌瘤而增大。 2014年，FDA针对非封闭式腹腔镜动力提供了指导 分碎术，一种在微创过程中快速取出大样本（例如子宫）的方法 外科手术。 FDA 确定动力粉碎机会增加接受手术的女性癌症扩散的风险 腹腔镜妇科手术治疗疑似良性肌瘤。预防隐性癌症的扩散 微创手术是许多手术中尚未解决的需求，包括：子宫切除术、 子宫肌瘤切除术、结肠切除术、卵巢切除术、脾切除术和肾切除术。 FDA 的指导意见离开了妇科 外科医生没有强大的工具来微创切除大子宫。主要技术开发于 对指南的响应称为封闭式手动粉碎，是一种标签外技术，需要将 将子宫放入容器中，然后用手术刀和抓紧器通过腹部切口将其取出或取出 阴道。该技术速度慢（通常需要 10-30 个手术刀刀片，需要 20-40 分钟）且无效 含有癌细胞（8-41% 有记录的容器破损）。另一种选择是开放手术，费用昂贵 （住院约 2.75 个晚上）并且相关发病率/死亡率很高（死亡率为 1:5000，严重死亡率为 1:20） 并发症）。 Claria Medical 正在开发一种组织遏制和提取系统 (TCES)，该系统将实现安全、 快速且经济有效地微创切除大子宫。手术速度和安全性的提高 Claria TCES 提供的手术可以在当天门诊进行，避免开放 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 向 FDA 申请 510(k) 许可。目标 1 侧重于设计优化和多个设计的执行 验证和确认协议包括：生物屏障测试、电气安全测试、生物相容性 根据 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，涉及四个方面 外科医生并利用手术模拟器和动物制定手术训练方案和验证程序 模型。目标 3 是由 34 名外科医生进行的总结性评估，验证培训方案和可用性 Claria TCES 在无辅助模拟子宫摘除手术中。 FDA 510(k) 批准后，~1.5- 该提案资助 2 年后，Claria 将进行额外的上市后临床评估， 商业启动以及良性和恶性组织切除其他适应症的临床研究。