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.

大多数育龄妇女会出现与月经有关的症状，并因此错过工作，这导致那些在感到不适的情况下上班的妇女因生病、缺勤和工作表现不佳而丧失生产力。在英国，这种生产力损失每年造成的损失估计为17.4亿英磅。目前处理月经症状的选择有限，很大程度上强调药物解决方案。这使得女性几乎没有选择来管理她们的症状。虽然这些疾病中的大多数多年来都没有得到诊断，但最终得到诊断的女性，如子宫内膜异位症、子宫肌瘤、经前综合症或其他疾病，往往只能得到有限的解决方案，通常从高强度的激素治疗开始，以子宫切除术结束。Samphire开发了一种可穿戴的、非侵入性的医疗设备，名为Nettle，其形式是发带，它使用个性化的神经调节技术来解决与情绪和疼痛相关的月经健康症状。该设备目前正在英国和欧盟获得监管批准。在该项目中，Samphire正在与伯明翰医疗技术研究所以及伯明翰大学合作进行一项以医院为基础的可行性研究，以测试将Nettle设备集成到NHS护理路径中的临床益处、健康经济学和可及性。在这项研究中，50名在该大学医院接受治疗的患者将与最先进的替代方案(如激素避孕药、促性腺激素释放激素替代疗法、抗抑郁药、子宫切除术)一起被提供安非他明作为一种治疗选择，并将对他们的结果进行跟踪和比较。这项研究的目的是论证将一种新的、非侵入性的医疗设备与更具侵入性的标准相结合的可行性，以照顾常见的和被忽视的妇女的健康状况。