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EXhaled Hydrogen Peroxide As a Marker of Lung Disease Study - Conformité Européenne (European Conformity) (EXHALE CE)

2020年8月26日更新者：Portsmouth Hospitals NHS Trust

An Observational Study to Determine the Usability of the Inflammacheck Device by Healthcare Providers in the Intended Use Environment - EXhaled Hydrogen Peroxide As a Marker of Lung diseasE Study - Conformité Européenne

This study is designed to test whether the Inflammacheck™ device is easy to use by healthcare professionals who would be using it in a clinic setting or in primary care. The data collected during this study will be used as part of the evidence needed to get the CE (Conformité Européenne) marking for the device.

CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). CE marking is essential for any medical devices used in the UK or the EU.

研究概览

地位

完全的

条件

护理点监测

详细说明

This observational study has been designed to evaluate the ability of healthcare providers to use the Inflammacheck™, an investigational medical device, to measure participants exhaled breath condensate (EBC) H2O2. The data will be used to support the CE marking of the Inflammacheck™ device.

A measure of the participants' EBC H2O2 will be measured on the Inflammacheck™ device to demonstrate usability and comprehension of the instructions for use.

There are no control measurements involved in the study, all of the participants' EBC H2O2 measurements will be performed using Inflammacheck™ only.

Only healthcare providers naïve to the Inflammacheck™ device will be eligible to take part in the assessment of usability. This is to ensure that the usability assessment will not be biased by prior knowledge of the device or its instructions. The only training provided will be an introductory presentation explaining the Clinical Investigation objectives.

The total time for participant involvement is one session comprising of:

Information & consent
EBC H2O2 measurement with Inflammacheck™

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

英国
- Hampshire
  - Portsmouth、Hampshire、英国、PO6 3LY
    - Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

NHS staff

描述

Inclusion Criteria:

Male or Female, aged 18 years or above.
Member of NHS staff at PHT.
Is a healthcare provider.
Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
Unable to comprehend the study and provide informed consent e.g. insufficient command of English in the absence of someone to adequately interpret.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
To determine the usability of the Inflammacheck device in health care providers 大体时间：immediately after the procedure	number of attempts taken to obtain a result	immediately after the procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Portsmouth Hospitals NHS Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年6月6日

初级完成 (实际的)

2019年10月9日

研究完成 (实际的)

2019年10月9日

研究注册日期

首次提交

2020年8月21日

首先提交符合 QC 标准的

2020年8月26日

首次发布 (实际的)

2020年8月28日

研究记录更新

最后更新发布 (实际的)