Phase
Condition
Deep Vein Thrombosis
Varicose Veins
Vascular Diseases
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years and ≤ 70 years of age.
Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinicalsymptoms, with or without visible varicosities, and confirmed by duplex ultrasoundimaging.
CEAP classification of C2, C3 or C4.
Ability to walk unassisted.
Ability to attend follow-up visits.
Ability to understand the requirements of the study and to provide written informedconsent.
"GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).
Exclusion
Exclusion Criteria:
Life expectancy < 1 year.
Regular pain medication.
Anticoagulation including Heparin or Coumadin.
Previous Deep Vein Thrombosis "DVT".
Previous superficial thrombophlebitis in "GSV".
Previous venous treatment on target limb.
Known Hyper-coagulable disorder.
Conditions which prevent routine vein treatment like:
Acute disease,
Immobilization or inability to ambulate, and
Pregnancy.
Tortuous "GSV", which in the opinion of the Investigator will limit catheterplacement. (no 2 primary access sites allowed).
Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
Known sensitivity to the cyanoacrylate "CA" adhesive.
Current participation in another clinical study involving an investigational agent ortreatment, or within the 30 days prior to enrollment.
Study Design
Study Description
Connect with a study center
Aareknudeklinikken
Naestved, 4700
DenmarkSite Not Available
Dermatologikum
Hamburg, 20354
GermanySite Not Available
Klinik Proebstle
Mannheim, D - 68161
GermanySite Not Available
Centrum Oosterawal
Alkmaar,
NetherlandsSite Not Available
Countess of Chester Hospital NHS Foundation Trust
Chester, CH2 1UL
United KingdomSite Not Available
The Whiteley Clinic
Guildford, GU2 7RF
United KingdomSite Not Available
Charing Cross Hospital
London, W6 8RF
United KingdomSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.