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Clinical Trial Summary

The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.


Clinical Trial Description

The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04384315
Study type Observational
Source Singapore General Hospital
Contact Charyl Yap
Phone 65767986
Email charyl.yap.j.q@sgh.com.sg
Status Recruiting
Phase
Start date August 1, 2019
Completion date December 1, 2022

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