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

GB-Veintech

Status: Unknown

Conditions: Venous Insufficiency

Treatments: Device: ESVV device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01346553

ESVV - PS-01

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

ESVV treatment

Experimental group

Description:

using ESVV device

Treatment:

Device: ESVV device