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.

项目摘要 /摘要 雷亚（Reia 影响50岁以上的50％以上的女性。 组织和肌肉削弱了子宫或阴道壁，在极端情况下会下降。 子宫下降了阴道的开口，悬挂在体外。 使用称为子宫的医疗装置，插入阴道管并起作用 作为支持降落器的灰烬。 使他们很难或不可能去除Ansert 与受影响的妇女及其从业人员的初步工作，设计创新的可折叠性香料 这将减少与插入和去除相关的疼痛和不适，使自主使用， 并满足了市场上当前麻烦的许多未满足的需求。 并优化其TOMEET机械和制造要求，执行关键路径 在准备批准临床用途并进行早期可行性的准备工作中进行测试 瑞亚（Reia）的临床试验将通过设计和原型 制造技术规模生产技术，进行台式机械测试以量化 在完整的生命周期内的功能和磨损特性，并进行生物相容性研究和 微生物测试。 评估Reia Pessary的表现和功能，然后进行多访问盛宴临床试验 与50位患者评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估的评估评估评估评估评估的评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估评估的评估评估评估评估评估评估评估的评估， 为了衡量进度和成功，已经建立了定义的评估标准。 赖亚（Reia）的创始团队由使用25年25年经验的使用泌尿疗法组成 以及在产品开发方面具有综合经验的流行音乐和三位Temale工程师， 运营制造和生产实践以及IP咨询。 在泌尿疗法，商业化的钙化设备和成功方面贡献专业知识 众多NIH资助项目的压缩与制造业有战略性 设施，测试实验室和监管顾问，以获取必要的设备， 资源和成功完成该项目的指导。 雷亚（Reia）致力于优化临床使用和制造的配体设计 有史以来第一个专门针对满足妇女需求的子宫。