Non-surgical treatment option for pelvic organ prolapse

盆腔器官脱垂的非手术治疗选择

• 批准号: 9907152
• 负责人: Paul Hanissian
• 金额: $ 99.4万
• 依托单位: REIA, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-25 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907152
• 关键词: Address; Adverse event; Affect; Age; Anatomic Models; Caliber; Caring; Clinical; Clinical Trials; Connective Tissue; Controlled Environment; Coughing; Critical Pathways; Data; Devices; Drainage procedure; Engineering; Environment; Equipment; Evaluation; Excision; Failure; Feasibility Studies; Female; Funding; Goals; Grant; Growth; Guidelines; Hand Osteoarthritis; Institutional Review Boards; Investigation; Laboratories; Left; Measures; Mechanics; Medical; Medical Device; Microbiology; Muscle; Nylons; Operative Surgical Procedures; Organ; Patients; Pelvic floor structure; Performance; Pessaries; Phase; Preparation; Prevalence; Process; Production; Property; Ptosis; Recommendation; Resources; Risk Assessment; Safety; Severities; Silicones; Site; Small Business Innovation Research Grant; Staphylococcus aureus; Symptoms; Techniques; Technology; Testing; Toxic Shock Syndrome Toxin-1; United States; United States National Institutes of Health; Uterus; Vagina; Vaginal Discharge; Validation; Visit; Woman; Work; alternative treatment; biomaterial compatibility; care providers; clinical efficacy; commercialization; cost; cytotoxicity; design; effectiveness evaluation; efficacy clinical trial; experience; feasibility trial; genotoxicity; implantation; in vivo; innovation; irritation; manufacturability; manufacturing facility; meetings; microbial; next generation; novel; pain reduction; pelvic organ prolapse; premature; product development; prototype; research and development; success; systemic toxicity; trial comparing

Project Summary / Abstract Reia is working to address a prevalent gynecological condition, pelvic organ prolapse (POP), which affects more than 50% of women over the age of 50. POP occurs when the pelvic floor connective tissue and muscles weaken, allowing the uterus or vaginal walls to descend. In extreme cases, the uterus descends through the opening of the vagina and hangs outside of the body. POP can be treated non-surgically with a medical device called a pessary which is inserted into the vaginal canal and acts as a shelf to support the descending organs. Commonly used pessaries have a fixed and rigid design, making them difficult or impossible for patients to remove and insert independently. Reia has done preliminary work with affected women and their practitioners to design an innovative collapsible pessary that will reduce pain and discomfort associated with insertion and removal, enable autonomous use, and address many unmet needs of current pessaries on the market. During Phase II, Reia will modify and optimize its pessary to meet mechanical and manufacturing requirements, perform critical path testing in preparation for approval by a local IRB for clinical use, and conduct early feasibility and feasibility clinical trials. Reia will achieve these aims by designing for and prototyping in realistic manufacturing techniques for production at scale, performing benchtop mechanical testing to quantify function and wear properties over a full lifecycle, and performing biocompatibility studies and microbiological testing. We will then conduct a single-visit early feasibility clinical trial with 15 patients to assess performance and function of Reia’s pessary, followed by a multi-visit feasibility clinical trial with 50 patients to evaluate the effectiveness, safety, comfort, and function of Reia’s pessary in day-to- day use. Defined evaluation criteria have been established in order to measure progress and success. Reia’s founding team is comprised of a urogynecologist with 25 years of experience fitting pessaries and treating POP and three female engineers with combined experience in product development, operational manufacturing and production practices, and IP advisory. Additionally, an advisory board contributes expertise in urogynecology, commercialization of medical devices, and successful completion of numerous NIH grant funded projects. Reia has strategically aligned with manufacturing facilities, testing laboratories, and regulatory consultants to gain access to necessary equipment, resources, and guidance to successfully complete this project. Reia is committed to optimizing its pessary design for clinical use and manufacture to bring to market the first-ever pessary specifically designed to address women’s needs.

项目总结/摘要 Reia正在努力解决一种流行的妇科疾病，盆腔器官脱垂（POP）， 影响了超过50%的50岁以上的女性。当骨盆底结缔组织 组织和肌肉变弱，使子宫或阴道壁下降。极端情况下 子宫通过阴道口下降，悬于体外。POP可以治疗 用一种叫做子宫托的医疗器械非手术地插入阴道腔， 作为支撑下行器官的架子。通常使用的子宫托具有固定和刚性的设计， 使得患者难以或不可能独立地取出和插入它们。雷亚已经做了 与受影响的妇女及其从业人员进行初步工作，以设计一种创新的可折叠子宫托 这将减少与插入和移除相关疼痛和不适，能够自主使用， 并解决了市场上现有子宫托的许多未满足的需求。在第二阶段，Reia将修改 并优化其子宫托，以满足机械和制造要求，执行关键路径 为准备当地IRB批准临床使用而进行的测试，并进行早期可行性研究， 可行性临床试验。Reia将通过设计和原型在现实中实现这些目标 大规模生产的制造技术，进行台式机械测试， 在整个生命周期内的功能和磨损性能，并进行生物相容性研究， 微生物检测然后，我们将对15名患者进行单次访视早期可行性临床试验 评估Reia子宫托的性能和功能，然后进行多次访视可行性临床试验 50例患者，以评价Reia阴道托的有效性、安全性、舒适性和功能， 日间使用。已经制定了明确的评价标准，以衡量进展和成功。 Reia的创始团队由一位拥有25年子宫托安装经验的泌尿妇科医生组成 并将POP和三名女性工程师与产品开发经验相结合， 运营制造和生产实践以及知识产权咨询。此外，咨询委员会 贡献了泌尿妇科学的专业知识，医疗器械的商业化， 完成了许多NIH赠款资助的项目。Reia在战略上与制造业保持一致 设施、测试实验室和监管顾问以获得必要的设备， 资源和指导，以成功地完成这个项目。 Reia致力于优化其临床使用和制造的子宫托设计，以推向市场 这是第一个专门针对女性需求而设计的子宫托。