An observational study in Point of Care Monitoring, sponsored by Portsmouth Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-28.
Sponsored by Portsmouth Hospitals NHS Trust · Observational
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.
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:
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 27 is below the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →Portsmouth Hospitals NHS Trust is the lead sponsor of 74 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
NHS staff
Exclusion Criteria:
To determine the usability of the Inflammacheck device in health care providers
number of attempts taken to obtain a result
Time frame: immediately after the procedure
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Portsmouth Hospitals NHS Trust