UnknownNot Applicable

Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore

Singapore30 participantsStarted 2019-08-01

Plain-language 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.

Who can participate

Age range21 Years – 90 Years

SexALL

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Inclusion criteria

✓. Age \>21 years, able to understand the requirements of the study and provide informed consent.
✓. C2 - C5 varicose veins / CVI
✓. Symptomatic primaryGSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
✓. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion criteria

✕. Current DVT or history of DVT
✕. Recurrent varicose veins
✕. Pregnant patients
✕. Arterial disease (ABPI\<0.8)
✕. Sepsis
✕. Patients who are unwilling to participate
✕. Inability or unwillingness to complete questionnaires
✕. Adverse reaction to sclerosant or cyanoacrylate

What they're measuring

Technical Success at time of procedure

Timeframe: Immediately post-procedure

Anatomical Success

Timeframe: 2 weeks to 12 months post-procedure

Trial details

NCT IDNCT04384315

SponsorSingapore General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-01

Contact for this trial

Charyl Yap

65767986 charyl.yap.j.q@sgh.com.sg

View on ClinicalTrials.gov More Varicose Veins trials