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NCT00954980 Clinical Trial

Evaluation of Endovenous Sclerotherapy for Treatment of Varicose Veins

Varicose Veins Clinical Trial

Official title:
Evaluation of Clinical Characteristics of Endovenous Sclerotherapy of Varicose Veins

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00954980
Other study ID # 14632
Secondary ID 20091634
Status Completed
Phase N/A
First received August 5, 2009
Last updated November 2, 2016
Start date May 2009
Est. completion date July 2016

Study information
Verified date November 2016
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The overall objective will be to evaluate clinical predictors of outcomes in patients who undergo endovenous sclerotherapy for the treatment of varicose veins.

Description:

A prospective cohort study of patients who undergo endovenous sclerotherapy over 2 years. There are no deviations in usual clinical assessment and care of patients seeking varicose vein treatment. The purpose of this protocol is only to collect clinical and biomarker information related to this standard treatment.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 2016
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of varicose veins

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Oklahoma Health Sciences Center campus at the OU Vascular Center Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of obliteratin (total or partial) of injected varicosity. assessment will be at 1, 12, and 26 weeks. Yes
Primary Improvement in venous stasis symptoms. assessment will be at 1, 12, and 26 weeks Yes
Primary Change in quality of life. assessment will be at 1, 12, and 26 weeks Yes
Primary Associations between clinical outcomes and biomarkers. assessment will be at 1, 12, and 26 weeks Yes
Secondary Recurrence of varicosities. assessment will be at 1, 12, and 26 weeks Yes
Secondary Adverse events reported following procedure. assessment will be at 1, 12, and 26 weeks Yes
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