Status:
UNKNOWN
High Intensity Focused Ultrasound in PAtients With 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 the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the Sonovein® device. The quality of life scores at bas...
Detailed Description
Sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. The high-intensity ultrasound beam is focused on the vein through a magnifying glass. As the...
Eligibility Criteria
Inclusion
- Age \>21 years, able to understand the requirements of the study and provide informed consent.
- C2 - C5 varicose veins / CVI
- Symptomatic primary GSV, 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 :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04339088
Start Date
March 1 2022
End Date
December 1 2023
Last Update
September 27 2021
Active Locations (1)
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1
Singapre General Hospital
Singapore, Singapore, 169608