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
About this trial
This is an interventional treatment trial for Primary Varicose Veins focused on measuring Deep venous insufficiency,
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
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
NCT ID
NCT04537052
First Posted
June 1, 2020
Last Updated
September 1, 2020
Sponsor
Kahramanmaras Sutcu Imam University
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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