NCT05580055

Brief Summary

The investigators are recruiting healthy volunteers to donate a finger prick blood sample or a small venous sample to Entia for the further development and testing of our blood analyser. The venous samples are taken by a registered nurse hired via a third party company. The results of the blood tests are not informed to the participants unless they explicitly ask for it.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 22, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

October 11, 2022

Last Update Submit

October 14, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • The difference in counts of the device tested blood vs the gold standard tested blood.

    Venous blood drawn will be tested on a laboratory analyser, in which the results will be compared against the results when tested on Entia's analyser.

    3 years

Study Arms (2)

Capillary Sample

This group donates finger prick blood samples to Entia for the purpose of development.

Diagnostic Test: Affinity

Venous Sample

This group donates venous blood samples to Enta, taken by a registered nurse.

Diagnostic Test: Affinity

Interventions

AffinityDIAGNOSTIC_TEST

Blood Analyser

Capillary SampleVenous Sample

Eligibility Criteria

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

Healthy volunteers, enrolled by invitation only

You may qualify if:

  • aged 18 years and above
  • healthy with no known conditions

You may not qualify if:

  • Has a known health condition, including blood-borne diseases
  • Inadequate understanding of the English language (written and verbal) that would require a translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Entia Ltd

London, WC1X 8LU, United Kingdom

Location

MeSH Terms

Interventions

Antibody Affinity

Intervention Hierarchy (Ancestors)

Immune System PhenomenaAntigen-Antibody Reactions

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 14, 2022

Study Start

October 22, 2021

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)