Peripheral Vascular DiseasesNCT04016649
The Mechanical Characterisation of Human Saphenous and Popliteal Vein
An observational study of Peripheral Vascular Diseases, run by University Hospital of Limerick at 1 site in Ireland.
Trial summary
Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- 21 Jan 2019to 21 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients unable to give informed consent
- Seriously ill/unconscious patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Limerick
Limerick, Limerick
Fiona Leahy, CNM Research, 061588394, fionac.leahy@hse.ie
About this study
Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.
Read the 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.
- Conditions
- Peripheral Vascular Diseases
- Medical subject headings
- Peripheral Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start21 Jan 2019
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- University of Limerick
- Responsible party
- Principal investigator, Fiona Leahy, University Hospital of Limerick
- Investigators
- Eamon Kavanagh, MD FRCSI, Principal investigator, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016649
- Sponsor's protocol ID
- DVS004
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2019
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Vein Tissue will be shared with research collaborators at the Univeristy of Limerick for the purpose of mechanical characterisation. Patient data will not leave the site of origin. No patient identifiable data will be shared. Vein tissue sample will be labelled with a study number and dated. No patient identifiable data will be labelled on the specimen container.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanical Characterisation of Human Saphenous and Popliteal Vein
- ClinicalTrials.gov ID
- NCT04016649
- Acronym / sponsor ID
- DVS004
- Conditions
- Peripheral Vascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Collaborators
- University of Limerick
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients unable to give informed consent
- Seriously ill/unconscious patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The identification of vein tissue mechanical distension and stretching properties.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. Vein Tissue will be shared with research collaborators at the Univeristy of Limerick for the purpose of mechanical characterisation. Patient data will not leave the site of origin. No patient identifiable data will be shared. Vein tissue sample will be labelled with a study number and dated. No patient identifiable data will be labelled on the specimen container.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eamon Kavanagh, MD FRCSI principal investigator
University Hospital of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases, run by University Hospital of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fiona Leahy, CNM Research (061588394, fionac.leahy@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The identification of vein tissue mechanical distension and stretching properties. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.