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NCT01000909 Clinical Trial

Venous Pressure Measurement of the Great Saphenous Vein Using Controlled Compression Ultrasound in Healthy Persons and Patients With Chronic Venous Disease as a New Non Invasive Method for Investigation of the Pathophysiology in Primary Varicose Veins

Chronic Venous Insufficiency Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01000909
Other study ID # CT-02-2009-USZ
Secondary ID
Status Recruiting
Phase N/A
First received October 22, 2009
Last updated June 28, 2010
Start date July 2009
Est. completion date July 2010

Study information
Verified date June 2010
Source University of Zurich
Contact 01 Studienregister MasterAdmins
Phone +41 (0)44 255 11 11
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

Part I:

Proof of concept trial to achieve normal venous pressure values under different provocation maneuvers in healthy persons

Part II:

Non invasive measurement of venous pressure under different provocation maneuvers in patients with chronic venous disease

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

Part I:

- Healthy persons without clinical signs of venous disease, informed consent

Part II:

- Patients with chronic venous disease with complete incompetence of the great saphenous vein (Hach IV)

- Informed consent

Exclusion criteria:

Part I:

- Clinical signs of venous disease, former deep vein thrombosis (DVT)

Part II:

- Former deep vein thrombosis, former vein surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound (venous pressure measurement)
increased venous pressure is predictive for chronic venous insufficiency

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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