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

Point of Care Monitoring Clinical Trial

— EXHALE CE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531449
• Other study ID #: PHT/2019/44
• Status: Completed
• Start date: June 6, 2019
• Est. completion date: October 9, 2019

Study information

• Verified date: August 2020
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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™

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 9, 2019
• Est. primary completion date: October 9, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Point of Care Monitoring

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the usability of the Inflammacheck device in health care providers	number of attempts taken to obtain a result	immediately after the procedure