Piloting the Samphire Nettle in clinical settings

在临床环境中试用 Samphire Nettle

• 批准号: 10110657
• 金额: $ 12.68万
• 依托单位: SAMPHIRE NEUROSCIENCE LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10110657
• 关键词: Piloting; Samphire; Nettle; clinical; settings

A large majority of reproductive-age women experience menstruation-related symptoms and have missed work as a result, which has led to a loss of productivity through sickness, absence and underperformance by those women who go to work while feeling unwell. The annual cost of this productivity loss in the UK has been estimated at £17.4B. Current options for dealing with menstrual symptoms are limited, with a large emphasis on pharmacological solutions. This leaves women with few options to manage their symptoms. While most of these conditions go undiagnosed for years, women who end up receiving a diagnosis, such as endometriosis, uterine fibroids, PMDD or others, are often left with limited solutions, often starting with intensive hormonal treatments and ending with hysterectomies.Samphire has developed a wearable, non-invasive medical device called the Nettle in the form of a hairband that uses personalised neuromodulatory technology to address mood and pain-related menstrual health symptoms. The device is currently undergoing regulatory clearance in the UK and EU.In this project, Samphire is collaborating with the Birmingham Healthcare Technologies Institute, as well as the University of Birmingham to run a hospital-based feasibility study that tests the clinical benefit, health economics and accessibility of integrating the Nettle device into the NHS care pathways. In this study, 50 patients undergoing treatment in the University hospital will be offered Nettle as a treatment option alongside state-of-the-art alternatives (such as hormonal contraceptives, GnRH replacement therapy, antidepressants, hysterectomy), and their outcomes will be followed and compared. The purpose of this study is to demonstrate the feasibility of integrating a novel, non-invasive medical device alongside more invasive standard of care for common, and neglected women's health conditions.

绝大多数生殖时代的女性经历了月经相关的症状，因此错过了工作，这导致那些在感到不适的同时上班的妇女因疾病，吸收和表现不佳而丧失了生产力。英国这种生产力损失的年度成本估计为17.4B英镑。当前处理月经症状的选择是有限的，重点是药物解决方案。这使妇女几乎没有选择来控制症状的选择。 While most of these conditions go uniagnosed for years, women who end up receiving a diagnosis, such as endometriosis, uterine fibroads, PMDD or others, are often left with limited solutions, often starting with intensive horsemonal treatments and ending with hysterectomies.Samphire has developed a wearable, non-invasive medical device called the Nettle in the form of a hairband that uses personalised neuromodulatory technology to address mood and与疼痛有关的月经症状。该设备目前正在英国和欧盟承保监管清除率。在该项目中，桑普郡正在与伯明翰医疗保健技术研究所以及伯明翰大学合作，旨在进行基于医院的可行性研究，以测试将Nettle设备集成到NHS Care Path的临床利益，健康经济学和可访问性。在这项研究中，将在大学医院接受治疗的50名患者将作为治疗选择提供与最先进的替代方案（例如马避孕药，GNRH替代疗法，抗抑郁药，子宫切除术）以及其结果并进行比较。这项研究的目的是证明将新颖的，非侵入性的医疗设备与对常见和被忽视的妇女健康状况的更具侵入性的护理标准相结合的可行性。