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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-01-31

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.

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Detailed Description

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Conditions

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Venous Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESVV treatment

using ESVV device

Group Type EXPERIMENTAL

ESVV device

Intervention Type DEVICE

wearing the ESVV device for 6 hours

Interventions

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ESVV device

wearing the ESVV device for 6 hours

Intervention Type DEVICE

Other Intervention Names

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Chronic Venous Insufficiency (CVI)treatment

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No