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CaVeP-DC: Capillary-Venous Paired Data Collection

Sponsor
Entia Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05926362
Collaborator
(none)
800
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Capillary-venous paired data collection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Capillary-Venous Paired Data Collection
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2026
    Anticipated Study Completion Date :
    Sep 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Coefficient of Variance of the difference between the lab results and the Liberty results [3 years]

      the coefficient of variance (CV) between the lab results and the liberty results would be compared. a lower CV value signifies a better performance of our device.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age >18 years old at the time of study entry

    • Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle of treatment

    • Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care

    • Can provide written informed consent

    Exclusion Criteria:

    • History of haematological malignancy

    • Inadequate use and understanding of the English language, requiring a translator

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT05926362
    Other Study ID Numbers:
    • IRAS: 329382
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    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
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jul 3, 2023