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: 10228246
• 负责人: Holly Rockweiler
• 金额: $ 115.15万
• 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/10228246
• 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 environment; 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

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.

这种快速轨道SBIR的目的是证明基于治疗性脱毛的安全性和功效 治疗乳腺癌幸存者和绝经后阴道干燥症状的医疗装置 女性。当今阴道干燥的最佳治疗方法都涉及使用激素。但是，荷尔蒙治疗 对于140万乳腺癌幸存者而被禁忌 癌症复发）。此外，由于长期 风险和不愉快的副作用。 Madorra开发了一种使用治疗超声检查的医疗设备 振兴阴道润滑，完全减轻阴道干燥的症状，而无需激素 治疗。马德拉（Madorra）团队进行的初步研究表明，有望进行阴道应用 治疗超声检查，以治疗阴道的妇女每天在家中使用阴道干燥 干燥。但是，这些研究中使用的经过修改的现成的超声设备很麻烦， 对研究参与者提出了重大的可用性挑战。研究中的妇女抱怨用户 界面，编程正确的超声剂量的挑战，定位难度和持有设备 在治疗期间，以及每次使用后清洁设备的负担。因此，是一种超声设备 可以有效地将所需的超声直接传递到阴道组织，同时容易使用（因此很容易 最终用户采用）。 Madorra基于此用户反馈开发了这样的设备，但是 尚未在临床上进行测试。这个快速曲目的SBIR提案将支持首次临床使用 Madorra设备。第一阶段涵盖了Madorra设备的小型单臂试验研究，II期 包括较大的随机，假对照的关键研究。试点研究（特定目的1-3）将使用 在Madorra设备上收集最初的临床使用经验数据，包括：安全性，生理证明 响应，易用性验证和初步功效。关键研究（特定目标4-6）将收集 具有统计学意义的安全性和功效数据，证明了Madorra设备治疗阴道的能力 与假装置相比，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立Madorra设备的临床功效。一旦FDA 已批准的Madorra设备将被商业化，并将允许数百万的乳腺癌幸存者和 绝经后妇女重新获得性健康并改善其生活质量。