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出现了与怀孕有关的症状，并因此错过了工作，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。英国每年的生产力损失估计为174亿英镑。目前处理月经症状的选择是有限的，主要强调药物解决方案。这使得妇女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未被诊断出来，但最终接受诊断的女性，如子宫内膜异位症，子宫肌瘤，PMDD或其他，往往只能得到有限的解决方案，通常从强化激素治疗开始，以子宫切除术结束。一种名为Nettle的非侵入性医疗设备，以发带的形式使用个性化的神经调节技术来解决情绪和疼痛问题，与月经有关的健康症状该设备目前正在接受英国和欧盟的监管许可。在这个项目中，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，测试将Nettle设备整合到NHS护理路径中的临床效益，健康经济学和可及性。在这项研究中，50名在大学医院接受治疗的患者将被提供Nettle作为一种治疗选择，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），并将随访和比较他们的结局。本研究的目的是证明将一种新型的非侵入性医疗器械与针对常见和被忽视的女性健康状况的更具侵入性的护理标准相结合的可行性。