Blood Testing at Entia

• Sponsor: Entia Ltd (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05580055
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 35.3
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Diagnostic Test: Affinity

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Blood Donation of Healthy Blood for Prototype Testing at Entia
• Actual Study Start Date: Oct 22, 2021
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Capillary Sample This group donates finger prick blood samples to Entia for the purpose of development.	Diagnostic Test: Affinity; Blood Analyser
Venous Sample This group donates venous blood samples to Enta, taken by a registered nurse.	Diagnostic Test: Affinity; Blood Analyser

Outcome Measures

Primary Outcome Measures

1. The difference in counts of the device tested blood vs the gold standard tested blood. [3 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• aged 18 years and above

• healthy with no known conditions

Exclusion Criteria:

• Has a known health condition, including blood-borne diseases

• Inadequate understanding of the English language (written and verbal) that would require a translator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Entia Ltd	London		United Kingdom	WC1X 8LU

Sponsors and Collaborators

• Entia Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Entia Ltd
• ClinicalTrials.gov Identifier: NCT05580055
• Other Study ID Numbers: 298186
• First Posted: Oct 14, 2022
• Last Update Posted: Oct 18, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 18, 2022