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

摘要 本快速通道SBIR的目标是证明基于治疗超声的 治疗乳腺癌幸存者和绝经后妇女阴道干燥症状的医疗器械 妇女今天最好的治疗阴道干燥的方法都涉及使用激素;然而，激素治疗 对于140万患有阴道干燥的乳腺癌幸存者来说是禁忌的（由于 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 风险和不良副作用。Madorra开发了一种医疗设备，使用治疗性超声波， 恢复阴道润滑，完全缓解阴道干燥症状，无需激素 疗法Madorra团队进行的初步研究表明， 治疗性超声波治疗阴道干燥时，每天在家里使用的妇女患有阴道 干燥。然而，在这些研究中使用的改进的现成的超声设备是笨重的， 对研究参与者提出了重大的可用性挑战。研究中的女性抱怨用户 界面，编程正确超声剂量的挑战，难以定位和固定器械 以及每次使用后清洁器械的负担。因此，提供了一种 可以有效地将所需的超声直接传递到阴道组织，同时易于使用（因此容易 最终用户需要）。Madorra根据用户的反馈开发了这样一款设备， 尚未进行临床试验。该快速通道SBIR提案将支持首次临床使用 Madorra装置I期包括Madorra器械的小型、单臂、初步研究，II期包括 包括一项更大的随机化、假手术对照研究。将使用初步研究（具体目标1-3） 收集Madorra器械的初始临床使用经验数据，包括：安全性、生理学证据 响应、易用性验证和初步疗效。初步研究（具体目标4-6）将收集 具有统计学显著性的安全性和有效性数据，证明了Madorra器械能够治疗阴道 干燥度与假器械相比。这些数据将提交给FDA，以支持器械 批准，并将用于确定Madorra器械的临床有效性。一旦FDA 一旦获得批准，Madorra设备将被商业化，并将允许数百万乳腺癌幸存者和 帮助绝经后妇女恢复性健康，提高生活质量。   1