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Pilot Study to Investigate the Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore
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.
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.
Age
21 - 90 years
Sex
ALL
Healthy Volunteers
No
Singapre General Hospital
Singapore, Singaopore, Singapore
Start Date
August 1, 2019
Primary Completion Date
December 1, 2021
Completion Date
December 1, 2022
Last Updated
September 27, 2021
30
ESTIMATED participants
Questionnaires
OTHER
Lead Sponsor
Singapore General Hospital
NCT07449728
NCT06811909
Data Source & Attribution
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