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The Mechanical of Characterisation of Human Saphenous and Popliteal Vein

Sponsor
University Hospital of Limerick (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04016649
Collaborator
University of Limerick (Other)
50
Enrollment
1
Location
49.9
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to mechanically characterise saphenous and popliteal vein segments that have been deemed waste following varicose vein procedures, lower limb amputation and lower limb bypass surgery.

    By characterising the stress-stretch relationship of the vein vessel wall, treatment techniques can be better understood. Mechanical device design can be bteer informed and the the suitability of vein as a conduit for bypass and AVF procedures can be assessed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Mechanical of Characterisation of Human Saphenous and Popliteal Vein
    Actual Study Start Date :
    Jan 21, 2019
    Anticipated Primary Completion Date :
    Jan 21, 2023
    Anticipated Study Completion Date :
    Mar 21, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The identification of vein tissue mechanical distension and stretching properties. [2 years]

      Vein tissue will undergo inflation-extension testing and unilaxial testing. The vein tissue will be cross-sectioned and rings of venous tissue will be mechanically characterised according to the properties exhibited.

    Eligibility Criteria

    Criteria

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

    • Male or Female patients aged 18 years or older

    • Patients undergoing varicose vein procedures or;

    • Patients undergoing lower limb amputation or;

    • Patients undergoing lower limb bypass surgery

    Exclusion Criteria:

    • Patients unable to give informed consent

    • Seriously ill/unconscious patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Limerick Limerick Ireland

    Sponsors and Collaborators

    • University Hospital of Limerick
    • University of Limerick

    Investigators

    • Principal Investigator: Eamon Kavanagh, MD FRCSI, University Hospital of Limerick

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fiona Leahy, Professor Eamon Kavanagh Prinicipal Investigator, University Hospital of Limerick
    ClinicalTrials.gov Identifier:
    NCT04016649
    Other Study ID Numbers:
    • CRSU017
    First Posted:
    Jul 11, 2019
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 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
    Additional relevant MeSH terms:
    Vascular Diseases
    Peripheral Vascular Diseases
    Peripheral Arterial Disease

    Study Results

    No Results Posted as of Jun 6, 2022