Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT00758420
Eligibility Criteria:
Inclusion Criteria:
* Males and Females 18-65 years old
* VEINES Sym Score less than 75 points
* Varicose Vein clinical classification CEAP 2, 3, 4, or 5
* Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
* Superficial venous disease manifested by both symptoms and visible varicosities
* Ability to comprehend and sign an informed consent document and completed study questionnaires in English
Exclusion Criteria:
* Incompetence of the SSV which substantially contributes to the filling of visible varicose veins
* Current or previous Deep Vein Thrombosis
* Leg obesity
* Peripheral arterial disease in the leg to be treated
* Reduced mobility
* Planned prolonged travel with limited mobility with in 4 weeks of treatment
* History of pulmonary embolism or stroke
* Major surgery, prolonged hospitalization or pregnancy within 3 months
* Current anticoagulation therapy (within 7 days of enrollment)
* Participation in a clinical study involving a investigational product within 3 months
* Major co-existing disease or clinically significant laboratory abnormalities
* Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions
* Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
* Pregnant or lactating women
* Current alcohol or drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00758420
Study Brief:
Protocol Section:
NCT00758420