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出境医 / 临床实验 / The Mechanical of Characterisation of Human Saphenous and Popliteal Vein

The Mechanical of Characterisation of Human Saphenous and Popliteal Vein

Study Description
Brief Summary:
Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.

Condition or disease
Peripheral Vascular Diseases

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
Layout table for study information
Study Type : Observational
Estimated 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 : January 21, 2019
Estimated Primary Completion Date : January 21, 2022
Estimated Study Completion Date : January 21, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.


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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Ireland
University Hospital Limerick
Limerick, Ireland
Sponsors and Collaborators
University Hospital of Limerick
University of Limerick
Investigators
Layout table for investigator information
Principal Investigator: Eamon Kavanagh, MD FRCSI University Hospital of Limerick
Tracking Information
First Submitted Date July 4, 2019
First Posted Date July 11, 2019
Last Update Posted Date April 30, 2021
Actual Study Start Date January 21, 2019
Estimated Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Mechanical of Characterisation of Human Saphenous and Popliteal Vein
Official Title The Mechanical of Characterisation of Human Saphenous and Popliteal Vein
Brief Summary 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Human saphenous and popliteal vein tissue segments deemed waste following varicose vein procedures, lower limb amputation and lower limb bypass surgery.
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.
Condition Peripheral Vascular Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 9, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 21, 2022
Estimated Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04016649
Other Study ID Numbers CRSU017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description:

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.
Responsible Party Fiona Leahy, University Hospital of Limerick
Study Sponsor University Hospital of Limerick
Collaborators University of Limerick
Investigators
Principal Investigator: Eamon Kavanagh, MD FRCSI University Hospital of Limerick
PRS Account University Hospital of Limerick
Verification Date April 2021

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