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

May 2, 2011 updated by: GB-Veintech

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zrifin, Israel
        • Assaf Harofe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESVV treatment
using ESVV device
Device: ESVV device
wearing the ESVV device for 6 hours
Other Names:
  • Chronic Venous Insufficiency (CVI)treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GB-Veintech

Investigators

  • Principal Investigator: Arie Bass, Prof., Assaf Harofe Medical Center, Zrifin, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

April 30, 2011

First Submitted That Met QC Criteria

May 2, 2011

First Posted (Estimate)

May 3, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2011

Last Update Submitted That Met QC Criteria

May 2, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESVV - PS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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