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

Not Applicable

• Conditions: Venous Insufficiency
• Interventions: Device: ESVV device

• Registration Number: NCT01346553
• Lead Sponsor: GB-Veintech

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-04-30
• Study First Submitted QC: 2011-05-02
• Last Update Submitted: 2011-05-02
• Study First Posted: 2011-05-03
• Last Update Posted: 2011-05-03
• Study Start: 2011-06
• Primary Completion: 2011-12
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESVV treatment	ESVV device	using ESVV device

Primary Outcome Measures

Name	Time	Method
The safety of using the ESVV for CVI treatment	6 hours	Adverse events will be documented

Secondary Outcome Measures

Name	Time	Method
Assessing the efficacy of using the ESVV for treatment of consequences of CVI.	6 hours	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)

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Zrifin, Israel