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.

绝大多数育龄妇女都有与月经有关的症状，因此错过了工作，这导致那些在身体不适的情况下上班的妇女因生病、缺勤和表现不佳而丧失了生产力。在英国，这种生产力损失的年度成本估计为174亿英镑。目前处理月经症状的选择是有限的，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控制她们的症状。虽然这些疾病中的大多数多年来都没有被诊断出来，但最终被诊断为子宫内膜异位症、子宫肌瘤、经前症候群（PMDD）或其他疾病的女性，往往只能得到有限的解决办法，通常从强化激素治疗开始，最后以子宫切除术结束。Samphire开发了一种名为“荨麻”的可穿戴式非侵入性医疗设备，它采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进行监管审批。在这个项目中，Samphire正在与伯明翰医疗保健技术研究所以及伯明翰大学合作，开展一项基于医院的可行性研究，测试将荨麻设备整合到NHS护理途径中的临床效益、健康经济学和可及性。在这项研究中，在大学医院接受治疗的50名患者将被提供荨麻作为治疗方案，同时提供最先进的替代方案（如激素避孕药、GnRH替代疗法、抗抑郁药、子宫切除术），并对其结果进行跟踪和比较。本研究的目的是证明将一种新颖的、非侵入性的医疗设备与更有侵入性的标准护理相结合的可行性，以治疗常见和被忽视的妇女健康状况。