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NCT04016649 Clinical Trial

The Mechanical Characterisation of Human Saphenous and Popliteal Vein

Peripheral Vascular Diseases Clinical Trial

Official title:
The Mechanical Characterisation of Human Saphenous and Popliteal Vein

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04016649
Other study ID # DVS004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2019
Est. completion date March 21, 2025

Study information
Verified date April 2024
Source University Hospital of Limerick
Contact Fiona Leahy, CNM Research
Phone 061588394
Email fionac.leahy@hse.ie
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date March 21, 2025
Est. primary completion date January 21, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Ireland University Hospital Limerick Limerick

Sponsors (2)
Lead Sponsor Collaborator
University Hospital of Limerick University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary The identification of vein tissue mechanical distension and stretching properties. 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. 2 years
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