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A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT)

Primary Purpose

Primary Varicose Veins

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ven Restoration Therapy
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Varicose Veins focused on measuring Deep venous insufficiency,

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency,
  • volunteering to take part in the study were included

Exclusion Criteria:

  • post-thrombotic or congenital deep venous insufficiency
  • Venous reflux disease in the GSV diagnosed by clinical symptoms
  • Local or systemic infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Onl Femoral vein

    Arm Description

    Ultrasound-guided controlled injection begins, and the venous diameter and gap between valves are reduced

    Outcomes

    Primary Outcome Measures

    femoral vein diameters
    reduce femoral vein diameter
    reflux times
    reduce reflux times

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2020
    Last Updated
    September 1, 2020
    Sponsor
    Kahramanmaras Sutcu Imam University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04537052
    Brief Title
    A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT)
    Official Title
    A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT) Erdinç EROĞLU
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 27, 2020 (Anticipated)
    Primary Completion Date
    December 30, 2020 (Anticipated)
    Study Completion Date
    January 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kahramanmaras Sutcu Imam University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Before the procedure, junctional femoral vein diameters and reflux times were measured. CEAP classification and Venous clinical severity scores (VCSS) were recorded. Chronic Venous Insufficiency Questionnaire (CIVIQ-20) were also recorded. Then, VRT was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. After the procedure, vein diameters and reflux times were measured again. All parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Varicose Veins
    Keywords
    Deep venous insufficiency,

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Onl Femoral vein
    Arm Type
    Experimental
    Arm Description
    Ultrasound-guided controlled injection begins, and the venous diameter and gap between valves are reduced
    Intervention Type
    Procedure
    Intervention Name(s)
    Ven Restoration Therapy
    Intervention Description
    This is a novel and promising method, applied percutaneously, in the treatment of deep venous insufficiency . In this method, developed based on the effects of compression garments, a polymer consisting of cyanoacrylate and hyaluronic acid is injected, with ultrasound-guidance, percutaneously around the femoral vein. In this way, the diameter of the vein is reduced, and function is restored to the inadequately functioning valve. The procedure is also called percutaneous valvuloplasty. The underlying idea in the development of this product was that hyaluronic acid might cause an increase in connective tissue, while cyanoacrylate could serve as an exoskeleton by forming heavy tissue.
    Primary Outcome Measure Information:
    Title
    femoral vein diameters
    Description
    reduce femoral vein diameter
    Time Frame
    9 months
    Title
    reflux times
    Description
    reduce reflux times
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency, volunteering to take part in the study were included Exclusion Criteria: post-thrombotic or congenital deep venous insufficiency Venous reflux disease in the GSV diagnosed by clinical symptoms Local or systemic infection

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT)

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