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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01346553

Enrollment

Registered

2011-05-03

Start date

2011-06-30

Completion date

2012-01-31

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Insufficiency

Keywords

Chronic Venous Insufficiency (CVI)

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.

Interventions

DEVICEESVV device

wearing the ESVV device for 6 hours

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
The safety of using the ESVV for CVI treatment	6 hours	Adverse events will be documented

Secondary

Measure	Time frame	Description
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)

Countries

Israel

Contacts

Primary ContactHanna Levy, Dr.

hanna@qsitemed.com+972-4-638-8837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026