Back to resultsSafety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)
Primary Purpose
Venous Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ESVV device
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency focused on measuring Chronic Venous Insufficiency (CVI)
Eligibility 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.
Sites / Locations
- Assaf Harofe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ESVV treatment
Arm Description
using ESVV device
Outcomes
Primary Outcome Measures
The safety of using the ESVV for CVI treatment
Adverse events will be documented
Secondary Outcome Measures
Assessing the efficacy of using the ESVV for treatment of consequences of CVI.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01346553
Brief Title
Safety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)
Official Title
Safety and Primary Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI) Sequel - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
GB-Veintech
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
Chronic Venous Insufficiency (CVI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESVV treatment
Arm Type
Experimental
Arm Description
using ESVV device
Intervention Type
Device
Intervention Name(s)
ESVV device
Other Intervention Name(s)
Chronic Venous Insufficiency (CVI)treatment
Intervention Description
wearing the ESVV device for 6 hours
Primary Outcome Measure Information:
Title
The safety of using the ESVV for CVI treatment
Description
Adverse events will be documented
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Assessing the efficacy of using the ESVV for treatment of consequences of CVI.
Description
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)
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna Levy, Dr.
Phone
+972-4-638-8837
Email
hanna@qsitemed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arie Bass, Prof.
Organizational Affiliation
Assaf Harofe Medical Center, Zrifin, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofe Medical Center
City
Zrifin
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Levy, Dr.
Phone
+972-4-638-8837
Email
hanna@qsitemed.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)
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