Status:
UNKNOWN
Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore
Lead Sponsor:
Singapore General Hospital
Conditions:
Varicose Veins
Venous Reflux
Eligibility:
All Genders
21-90 years
Brief 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 an...
Detailed 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 ca...
Eligibility Criteria
Inclusion
- 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
- 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
- GSV, SSV or AASV severely tortuous
- Life expectancy \< 1 year
- Active treatment for malignancy other than non-melanoma skin cancer
- Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
- Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04384315
Start Date
August 1 2019
End Date
December 1 2022
Last Update
September 27 2021
Active Locations (1)
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1
Singapre General Hospital
Singapore, Singaopore, Singapore, 169608