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

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01346553
• Other study ID #: ESVV - PS-01
• Status: Not yet recruiting
• Phase: N/A
• First received: April 30, 2011
• Last updated: May 2, 2011
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2011
• Source: GB-Veintech
• Contact: Hanna Levy, Dr.
• Phone: +972-4-638-8837
• Email: hanna[@]qsitemed.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Device:
• ESVV device
wearing the ESVV device for 6 hours

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
GB-Veintech

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of using the ESVV for CVI treatment	Adverse events will be documented	6 hours	Yes
Secondary	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)	6 hours	No