The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
This is a post market, observational study of closure of the great saphenous vein "GSV". Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional comparison points may include measurements of pain and/or length of time to return to work.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
Aareknudeklinikken
Næstved, Denmark
Dermatologikum
Hamburg, Germany
Klinik Proebstle
Mannheim, Germany
Centrum Oosterawal
Alkmaar, Netherlands
Comparative Duplex Ultrasound
The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux.
Time frame: Immediately Post-procedure
Safety
The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).
Time frame: Immediately post-op through 6 month Follow-up "FU"
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Countess of Chester Hospital NHS Foundation Trust
Chester, United Kingdom
The Whiteley Clinic
Guildford, United Kingdom
Charing Cross Hospital
London, United Kingdom