Capillary-Venous Paired Collection (CaVe)

July 28, 2026 updated by: Entia Ltd

CApillary-VEnous Paired Collection (CAVE)

This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples from the same participants will be tested on the investigation system.

The participants' CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and venous blood samples on the investigational system. At certain sites, the usability of the investigational system is observed to evaluate the usability of the system.

The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Fife
      • Dunfermline, Fife, United Kingdom, KY12 0SU
        • Queen Margaret Hospital
    • Wrexham County Borough
      • Wrexham, Wrexham County Borough, United Kingdom, LL13 7YP
        • North Wales Clinical Research Facility
  • United States
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scott & White - Temple

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer patients undergoing SACT treatment

Description

Inclusion Criteria:

  • Informed Consent signed by the subject
  • Age ≥21 years old at the time of study entry
  • Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and/or targeted therapy) for solid organ malignancy
  • Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care OR willing to undergo a research-specific venous draw to obtain a complete/full blood count (CBC/FBC)

Exclusion Criteria:

  • History or current diagnosis of hematological malignancy (including bone and lymph)
  • Patients who self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty, and who do not have a carer who can assist them.
  • Patients who have had prior experience using Liberty
  • Inadequate use and understanding of the English language, requiring a translator

Carer eligibility:

  • Age ≥ 21 years old at the time of study entry
  • Can provide written informed consent
  • Do NOT self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty
  • Have NOT had prior experience using Liberty
  • Adequate use and understanding of the English language; NOT requiring a translator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 3 tests on the investigational system and a comparator venous sample for testing on a comparator system. For certain sites, an additional venous sample will also be tested on the investigational system. The venous CBC results from the comparator system will be compared to the results of both capillary and venous specimens obtained by the investigational system.
Device: Entia Liberty System
See arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate the measurement performance of the investigational system (regression)
Time Frame: through study completion, estimated 6 months
The plotted difference between the measured parameters of the comparator and investigational system will provide the regression, which will be checked against pre-determined acceptance criteria.
through study completion, estimated 6 months
To validate the measurement performance of the investigational system (CV and SD)
Time Frame: through study completion, estimated 6 months
The difference between the measured parameters of the comparator and investigational system will inform the Coefficient of Variation and Standard Deviation of the dataset, which will be checked against pre-determined acceptance criteria.
through study completion, estimated 6 months
To validate the measurement performance of the investigational system
Time Frame: through study completion, estimated 6 months
The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria.
through study completion, estimated 6 months
To validate the usability of the Liberty Analyzer System in a simulated home environment
Time Frame: Through study completion. Estimated 6 months
Participant to complete a usability questionnaire following use of Liberty. Observer to complete usability checklist during participants' use of Liberty
Through study completion. Estimated 6 months
To prove equivalence in the measurement performance between the sampling matrices
Time Frame: through study completion, estimated 6 months
Performance comparison (bias, %bias, regression, CV) between the testing matrices (capillary whole blood and venous whole blood) on Liberty.
through study completion, estimated 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Entia Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAVE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe