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: 10452463
• 负责人: Paul Hanissian
• 金额: $ 16.08万
• 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 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10452463
• 关键词: Address; Affect; Age; Appointment; Area; Award; Budgets; COVID-19 pandemic; Clinic; Clinical Trials; Connective Tissue; Equipment; Evaluation; Excision; Maintenance; Mechanics; Medical; Medical Device; Muscle; Operative Surgical Procedures; Organ; Patients; Pelvic floor structure; Pessaries; Phase; Population; Preparation; Resources; S Phase; Safety; Site; Testing; Toxic effect; United States; Uterus; Vagina; Visit; Woman; Work; alternative treatment; biomaterial compatibility; design; effectiveness evaluation; feasibility trial; innovation; meetings; metropolitan; novel; pain reduction; pelvic organ prolapse; recruit; verification and validation

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, and in extreme cases, hang 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 rigid design, making them difficult or impossible for patients to remove and insert independently. Consequently, patients must rely on their practitioners for regular pessary maintenance appointments, which are burdensome for both patients and practitioners alike. Reia has designed an innovative collapsible pessary that will enable autonomous use, reduce pain and discomfort associated with insertion and removal, and address unmet needs of current pessaries. During Year 1 of the Phase II award, Reia has successfully optimized its pessary to meet mechanical and manufacturing requirements, commenced necessary biocompatibility studies, and conducted an early feasibility clinical trial. In Year 2, Reia will complete all verification and validation to support 510(k) clearance including a multi-visit feasibility trial to evaluate effectiveness, safety, comfort, and function of Reia’s pessary when in use. Reia’s Phase II budget included a suite of biocompatibility testing in preparation for 510(k) clearance; however, during a pre-submission meeting in November, 2019, the FDA requested that Reia expand its originally proposed biocompatibility testing to include subacute & subchronic toxicity and an extractable/leachable evaluation. This originally unforeseen biocompatibility testing will be required in the 510(k) clearance application for Reia’s pessary and is an expansion of the work outlined in Reia’s Phase II application. Reia’s Phase II application outlined Reia’s plans to conduct the feasibility trial at Dartmouth-Hitchcock Clinic (Hanover, NH). However, Reia has expanded the feasibility trial to include three additional sites located in larger metropolitan areas. Expanding the trial will increase recruitment rate to alleviate delays caused by the COVID- 19 pandemic and allow Reia’s trial to be conducted with a more diverse, and thus representative, population. Reia’s founding team, advisory board, and strategic partners allow Reia access to the necessary equipment, resources, and guidance to successfully complete the Aims outlined in Reia’s Phase II application. With the addition of this supplement, Reia will be able to complete all verification and validation to support its 510(k) clearance application and bring to market the first-ever pessary specifically designed to address women’s needs.

项目概要/摘要 Reia 正在致力于解决一种常见的妇科疾病——盆腔器官脱垂 (POP)，该疾病影响更多人 超过 50% 的 50 岁以上女性。当盆底结缔组织和肌肉减弱时，就会发生 POP， 使子宫或阴道壁下降，在极端情况下，可能会悬挂在体外。 使用称为子宫托的医疗装置进行非手术治疗，将其插入阴道管并发挥作用 作为支撑下降器官的架子，常用的子宫托具有刚性的设计，这使得它们变得困难。 或者患者无法独立取出和插入。 护理人员定期进行子宫托维护预约，这对患者和患者来说都是负担 Reia 设计了一种创新的可折叠子宫托，可以自主使用，减少 与插入和取出相关的疼痛和不适，并解决当前子宫托未满足的需求。 在第二阶段奖励的第一年，Reia 成功优化了其子宫托以满足机械和 制造要求，开始必要的生物相容性研究，并进行早期可行性研究 在第二年，Reia 将完成所有验证和确认以支持 510(k) 许可，包括 多次访问可行性试验，以评估 Reia 子宫托在使用时的有效性、安全性、舒适度和功能。 Reia 的第二阶段预算包括一套生物相容性测试，为 510(k) 许可做准备； 在 2019 年 11 月的提交前会议上，FDA 要求 Reia 扩大其最初提议的范围 生物相容性测试，包括亚急性和亚慢性毒性以及可提取/可浸出评估。 Reia 的 510(k) 许可申请中将需要进行原本不可预见的生物相容性测试 子宫托，是 Reia 二期应用中概述的工作的扩展。 Reia 的二期申请概述了 Reia 在达特茅斯-希区柯克诊所进行可行性试验的计划 （新罕布什尔州汉诺威）然而，Reia 已扩大了可行性试验范围，将位于更大的三个地点纳入其中。 扩大试验范围将提高招募率，以缓解新冠肺炎造成的延误。 19 大流行，使 Reia 的试验能够在更多样化、更具代表性的人群中进行。 Reia 的创始团队、顾问委员会和战略合作伙伴使 Reia 能够获得必要的设备、 成功完成 Reia 第二阶段申请中概述的目标的资源和指导。 添加此补充后，Reia 将能够完成所有验证和确认以支持其 510(k) 批准申请并将首款专为满足女性需求而设计的子宫托推向市场。