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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 because the information has not been verified recently.
Verified April 2011 by GB-Veintech.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
GB-Veintech
ClinicalTrials.gov Identifier:
NCT01346553
First received: April 30, 2011
Last updated: May 2, 2011
Last verified: April 2011
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346553

Contacts
Contact: Hanna Levy, Dr. +972-4-638-8837 hanna@qsitemed.com

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

No publications provided

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

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

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013