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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by GB-Veintech.
Recruitment status was:  Not yet recruiting
Information provided by:
GB-Veintech Identifier:
First received: April 30, 2011
Last updated: May 2, 2011
Last verified: April 2011
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.

Condition Intervention
Venous Insufficiency
Device: ESVV device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Primary Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI) Sequel - A Pilot Study

Further study details as provided by GB-Veintech:

Primary Outcome Measures:
  • The safety of using the ESVV for CVI treatment [ Time Frame: 6 hours ]
    Adverse events will be documented

Secondary Outcome Measures:
  • Assessing the efficacy of using the ESVV for treatment of consequences of CVI. [ Time Frame: 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)

Estimated Enrollment: 15
Study Start Date: June 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESVV treatment
using ESVV device
Device: ESVV device
wearing the ESVV device for 6 hours
Other Name: Chronic Venous Insufficiency (CVI)treatment


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01346553

Contact: Hanna Levy, Dr. +972-4-638-8837

Assaf Harofe Medical Center Not yet recruiting
Zrifin, Israel
Contact: Hanna Levy, Dr.    +972-4-638-8837   
Sponsors and Collaborators
Principal Investigator: Arie Bass, Prof. Assaf Harofe Medical Center, Zrifin, Israel
  More Information

Responsible Party: Dr. Hanna levy, GB-Veintech Identifier: NCT01346553     History of Changes
Other Study ID Numbers: ESVV - PS-01
Study First Received: April 30, 2011
Last Updated: May 2, 2011

Keywords provided by GB-Veintech:
Chronic Venous Insufficiency (CVI)

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases processed this record on April 28, 2017