NCT04531449

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 21, 2020

Last Update Submit

August 26, 2020

Conditions

Point of Care Monitoring

Outcome Measures

Primary Outcomes (1)

  • To determine the usability of the Inflammacheck device in health care providers

    number of attempts taken to obtain a result

    immediately after the procedure

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

NHS staff

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 28, 2020

Study Start

June 6, 2019

Primary Completion

October 9, 2019

Study Completion

October 9, 2019

Last Updated

August 28, 2020

Record last verified: 2020-08

Locations

GB(1)