The Mechanical Characterisation of Human Saphenous and Popliteal Vein

NCT04016649 | Recruiting DMC

• 1 other identifier: DVS004
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population will consist of individuals under the care of a Vascular Consultant. Patients will be asked to participate if they are going for a procedure in which there will be vein tissue waste that would usually be discarded in the operating theatre. The procedures of interest are Varicose Vein Procedures, Lower Limb Amputation and Lower Limb Bypass Surgery.

You may qualify if:

• 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

You may not qualify if:

• Patients unable to give informed consent
• Seriously ill/unconscious patients

Sponsors & Collaborators

• University Hospital of Limerick: lead
• University of Limerick: collaborator

Study Sites (1)

University Hospital Limerick

Limerick, Limerick, Ireland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human saphenous and popliteal vein tissue segments deemed waste following varicose vein procedures, lower limb amputation and lower limb bypass surgery.

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eamon Kavanagh, MD FRCSI

  University Hospital of Limerick

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Leahy, CNM Research

CONTACT

061588394; fionac.leahy@hse.ie

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Eamon Kavanagh Prinicipal Investigator

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 11, 2019
• Study Start: January 21, 2019
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): March 21, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)