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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2011
CompletedFirst Posted
Study publicly available on registry
May 3, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMay 3, 2011
April 1, 2011
6 months
April 30, 2011
May 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety of using the ESVV for CVI treatment
Adverse events will be documented
6 hours
Secondary Outcomes (1)
Assessing the efficacy of using the ESVV for treatment of consequences of CVI.
6 hours
Study Arms (1)
ESVV treatment
EXPERIMENTALusing ESVV device
Interventions
wearing the ESVV device for 6 hours
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GB-Veintechlead
Study Sites (1)
Assaf Harofe Medical Center
Zrifin, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arie Bass, Prof.
Assaf Harofe Medical Center, Zrifin, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 30, 2011
First Posted
May 3, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
May 3, 2011
Record last verified: 2011-04