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

Last updated: September 23, 2021
Sponsor: Singapore General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Venous Thrombosis

Claudication

Varicose Veins

Treatment

N/A

Clinical Study ID

NCT04384315
2019/2544
  • Ages 21-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Current DVT or history of DVT
  2. Recurrent varicose veins
  3. Pregnant patients
  4. Arterial disease (ABPI<0.8)
  5. Sepsis
  6. Patients who are unwilling to participate
  7. Inability or unwillingness to complete questionnaires
  8. Adverse reaction to sclerosant or cyanoacrylate
  9. GSV, SSV or AASV severely tortuous
  10. Life expectancy < 1 year
  11. Active treatment for malignancy other than non-melanoma skin cancer
  12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
  13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venousdisease

Study Design

Total Participants: 30
Study Start date:
August 01, 2019
Estimated Completion Date:
December 01, 2022

Study 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.

Connect with a study center

  • Singapre General Hospital

    Singapore, Singaopore 169608
    Singapore

    Active - Recruiting

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