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.

摘要 在美国，每年进行大约500，000例直肠切除术，通常用于子宫切除术。 由于纤维瘤而增大。2014年，FDA提供了针对不含腹腔镜电源的指南， 分碎术，一种在微创手术中快速取出大样本（如子宫）的方法 手术FDA确定，电动粉碎器增加了女性癌症扩散的风险， 腹腔镜妇科手术治疗良性子宫肌瘤预防隐性癌症的传播 微创手术在许多手术中是一种未解决的需求，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的指南将妇科 外科医生没有很好的工具来微创切除大子宫。主要技术是在 对指南的反应，称为手动粉碎，是一种标签外技术，需要将 将子宫放入容器中，用手术刀和抓钳通过腹部切口或外部将其取出 阴道该技术缓慢（通常需要10-30个手术刀片，需要20-40分钟），并且无效 在含有癌细胞（8-41%记录的容器破裂）。另一种选择是开放手术， （住院约2.75晚），并具有较高的相关发病率/死亡率（1：5000死亡率，1：20严重 并发症）。 Claria Medical正在开发一种组织容纳和提取系统（TCES）， 快速且经济有效的微创切除大子宫。提高手术速度和安全性， Claria TCES提供的手术可以在同一天的门诊病人中进行， 手术、并发症和长期住院。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侧重于设计优化和几个设计的执行 验证和确认方案，包括：生物屏障测试、电气安全测试、生物相容性 FDA要求的测试、灭菌和有效期测试。Aim 2是一项形成性可用性研究， 外科医生和开发手术培训协议和验证程序与手术模拟器和动物 模型目标3是一项总结性评价，34名外科医生确认了培训方案和 Claria TCES在无辅助模拟子宫摘除术期间。FDA 510（k）批准后，约1.5- 在本提案获得资助后2年，Claria将进行额外的上市后临床评价， 商业发布，以及良性和恶性组织切除的其他适应症的临床研究。