Safety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)

Study Overview
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Brief Summary
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The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. The external device is located above the failed deep vein and exerts synchronized intermittent regulated pressure on it. Alteration in the vein structure is occurred and the blood flows in the cephalad direction, preventing the return toward the feet. The device is synchronized with the calf muscles pump to function as a one-way venous valve. This study was design in order to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic venous insufficiency.

Official Title
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Safety and Primary Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI) Sequel - A Pilot Study

Conditions
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Venous Insufficiency

Intervention / Treatment
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* Device: ESVV device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females age 18 and up. Patient is diagnosed to have deep chronic venous insufficiency (CVI) proved by recent duplex examination. Patient able to comprehend and give informed consent for participation in this study. Patient must commit to both screening and treatment visits. Patient must sign the Informed Consent Form. Exclusion Criteria: Acute deep vein thrombosis. Chronic deep vein obstruction. Peripheral arterial occlusive disease. Ankle edema that is not caused by chronic venous insufficiency Partial or complete immobility. Pregnancy. Known cognitive disorder. Drug abuse. Patient objects to the study protocol. Concurrent participation in any other clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESVV treatment<br>using ESVV device | Device: ESVV device<br>* wearing the ESVV device for 6 hours<br>* Other names: Chronic Venous Insufficiency (CVI)treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of using the ESVV for CVI treatment | Adverse events will be documented | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the efficacy of using the ESVV for treatment of consequences of CVI. | The efficacy of using the ESVV for the treatment of deep CVI will be established by an increase of at least 100% in PPG recovery time (RT) | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Venous Insufficiency (CVI)