Status:
UNKNOWN
Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Lead Sponsor:
Singapore General Hospital
Conditions:
Varicose Veins
Venous Reflux
Eligibility:
All Genders
21-90 years
Brief Summary
To assess the efficacy of the Venablock©Vein Sealing System (VBVS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting in a multi-racial Asian population in...
Detailed Description
The purpose of the Registry to Investigate the Efficacy and Safety of Venablock©Vein Sealing System for Varicose Veins in Singapore (RIVERIA), is to investigate the performance of cyanoacrylate glue c...
Eligibility Criteria
Inclusion
- Age \> 21 years old and ability to understand the requirements of the study and to provide informed consent
- C2-C6 varicose veins/CVI (CEAP Class 1 patients will be excluded)
- 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 had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position
Exclusion
- Current DVT or history of DVT
- Pregnant patients
- Arterial disease (ABPI\<0.8)
- Sepsis
- Patient who are unwilling to participate
- Inability or unwillingness to complete the time-point questionnaires
- Adverse reaction to sclerosant or cyanoacrylate previously
- Multiple drug allergies
- Previous intervention with the VenaSeal cyanoacrylate glue closure system
- Severely tortuous GSV, SSV or AASV
- 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 :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04339075
Start Date
October 1 2019
End Date
October 1 2021
Last Update
November 2 2020
Active Locations (1)
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1
Singapre General Hospital
Singapore, Singapore, 169608