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.

这个快速通道SBIR的目标是证明一种基于超声治疗的安全性和有效性