Developing a novel, non-hormonal treatment paradigm for vaginal dryness in breast cancer survivors

开发一种新颖的非激素治疗模式来治疗乳腺癌幸存者的阴道干燥

• 批准号: 10247092
• 负责人: Holly Rockweiler
• 金额: $ 84.85万
• 依托单位: MADORRA, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247092
• 关键词: Abate; Abstinence; Acoustics; Adjuvant; Adopted; Adverse event; Anatomy; Atopobium vaginae; Award; Biomedical Engineering; Blood flow; Breast Cancer Treatment; Breast Cancer survivor; Client satisfaction; Clinical; Clinical Research; Clinical Trials; Competence; Control Groups; Coupling; Data; Data Collection; Device Approval; Devices; Doctor of Philosophy; Dose; Double-Blind Method; Electronics; Energy Transfer; Engineering; Estrogens; FDA approved; Feedback; Funding; Goals; Gold; Health; Holly; Home; Hormonal; Hormone replacement therapy; Hormone use; Hormones; Human; Incidence; Institutional Review Boards; Interview; Knowledge; Love; Lubricants; Lubrication; Measures; Mechanics; Medical; Medical Device; Mental Depression; Pain; Participant; Patient Outcomes Assessments; Pharmaceutical Preparations; Phase; Physiological; Pilot Projects; Positioning Attribute; Postmenopause; Protocols documentation; Quality of life; Randomized; Research; Risk; Safety; Severities; Sexual Health; Small Business Innovation Research Grant; Surveys; Survivors; Symptoms; Temperature; Testing; Therapeutic; Therapeutic Uses; Tissues; Ultrasonography; United States National Institutes of Health; Universities; Vagina; Validation; Woman; Women' s Health; arm; base; cancer recurrence; cancer risk; clinical efficacy; commercialization; compliance behavior; design; experience; hormone therapy; improved; indexing; novel; operation; portability; primary endpoint; reduce symptoms; research and development; response; secondary endpoint; sham-controlled study; side effect; standard care; study population; symptom treatment; treatment arm; usability; vaginal dryness

Abstract The goal of this Fast-Track SBIR is to demonstrate the safety and efficacy of a therapeutic-ultrasound-based medical device to treat the symptoms of vaginal dryness for breast cancer survivors and postmenopausal women. Today's best treatments for vaginal dryness all involve the use of hormones; yet, hormonal treatments are contraindicated for the 1.4 million breast cancer survivors suffering from vaginal dryness (due to the risk of cancer recurrence). Further, millions of postmenopausal women avoid hormone use because of the long-term risks and unpleasant side effects. Madorra has developed a medical device that uses therapeutic ultrasound to revitalize vaginal lubrication, abating symptoms of vaginal dryness completely without the need for hormone therapy. Preliminary research conducted by the Madorra team has indicated the promise of vaginally applied therapeutic ultrasound to treat vaginal dryness when used daily in the home by women suffering from vaginal dryness. However, the modified off-the-shelf ultrasound devices used in those studies were cumbersome and posed significant usability challenges for the study participants. Women in the study complained about the user interface, challenges in programming the correct ultrasound dose, difficulty positioning and holding the device during therapy, and the burdens of cleaning the device after each use. Accordingly, an ultrasound device that can effectively deliver desired ultrasound directly to vaginal tissue while being easily used (and hence readily adopted by end users) is required. Madorra has developed such a device based on this user feedback, but it has not yet been tested clinically. This Fast-Track SBIR proposal would support the first clinical use of the Madorra device. Phase I encompasses a small, single-arm, Pilot Study of the Madorra device, and Phase II comprises a larger randomized, sham-controlled Pivotal Study. The Pilot Study (Specific Aims 1-3) will be used to gather initial clinical use experience data on the Madorra device, including: safety, proof of physiologic response, validation for ease of use, and preliminary efficacy. The Pivotal Study (Specific Aims 4-6) will collect statistically significant safety and efficacy data demonstrating the Madorra device's ability to treat vaginal dryness in comparison to a sham device. These data will be submitted to the FDA in support of device approval and will serve to irrevocably establish the clinical efficacy of the Madorra device. Once FDA approved, the Madorra device will be commercialized and will allow millions of breast cancer survivors and postmenopausal women to regain their sexual wellness and improve their quality of life.   1

抽象的 该快速通道 SBIR 的目标是证明基于超声治疗的安全性和有效性 用于治疗乳腺癌幸存者和绝经后阴道干燥症状的医疗设备 女性。当今治疗阴道干燥的最佳方法都涉及使用激素。然而，荷尔蒙治疗 对于 140 万患有阴道干燥的乳腺癌幸存者来说是禁忌的（因为存在以下风险） 癌症复发）。此外，数以百万计的绝经后妇女避免使用激素，因为长期 风险和令人不快的副作用。 Madorra 开发了一种医疗设备，利用治疗超声波来治疗 恢复阴道润滑，完全减轻阴道干燥症状，无需激素 治疗。 Madorra 团队进行的初步研究表明了阴道应​​用的前景 患有阴道疾病的女性每天在家中使用治疗性超声波治疗阴道干燥 干燥。然而，这些研究中使用的经过改进的现成超声设备非常笨重并且 给研究参与者带来了重大的可用性挑战。研究中的女性抱怨用户 界面、对正确超声剂量进行编程的挑战、定位和握住设备的困难 治疗期间的负担，以及每次使用后清洁设备的负担。因此，超声装置 可以有效地将所需的超声波直接传递到阴道组织，同时易于使用（因此很容易 最终用户采用）是必需的。 Madorra 根据用户反馈开发了这样的设备，但它 尚未经过临床测试。该快速通道 SBIR 提案将支持该药物的首次临床使用 马多拉装置。第一阶段包括对 Madorra 装置的小型单臂试点研究，第二阶段包括 包括一项更大的随机、假对照关键研究。将使用试点研究（具体目标 1-3） 收集 Madorra 设备的初步临床使用经验数据，包括：安全性、生理学证明 响应、易用性验证和初步功效。关键研究（具体目标 4-6）将收集 统计上显着的安全性和有效性数据证明了 Madorra 装置治疗阴道疾病的能力 与假设备相比的干燥度。这些数据将提交给 FDA 以支持设备 批准并将不可撤销地确定 Madorra 装置的临床疗效。曾经FDA 获得批准后，Madorra 设备将商业化，并使数百万乳腺癌幸存者和 绝经后妇女恢复性健康并提高生活质量。   1