- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04531449
EXhaled Hydrogen Peroxide As a Marker of Lung Disease Study - Conformité Européenne (European Conformity) (EXHALE CE)
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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™
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Hampshire
-
Portsmouth, Hampshire, Storbritannia, PO6 3LY
- Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
To determine the usability of the Inflammacheck device in health care providers
Tidsramme: immediately after the procedure
|
number of attempts taken to obtain a result
|
immediately after the procedure
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PHT/2019/44
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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