Status:

UNKNOWN

Efficacy and Safety of Endovenous Microwave Ablations for Treatment of Varicose Veins in Singapore

Lead Sponsor:

Singapore General Hospital

Conditions:

Venous Insufficiency

Varicose Veins

Eligibility:

All Genders

21-99 years

Phase:

NA

Brief Summary

The purpose of this study is to assess change in patient's symptoms before and after Endovenous Microwave Ablation (EMA) as treatment for varicose veins. At the same time, it is to evaluate the effect...

Detailed Description

Healthy leg veins have valves that allow blood to move in one direction from the lower leg to the heart. These valves open when blood is flowing toward the heart and then quickly close to stop any bac...

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 AASV diameters of 3mm to 12mm in the standing postition.

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 us of narcotic analgesia or NSAIDS to control pain associated with venous disease

Key Trial Info

Start Date :

May 9 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2021

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04524793

Start Date

May 9 2020

End Date

December 1 2021

Last Update

September 27 2021

Active Locations (1)

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1

Singapore General Hospital

Singapore, Singapore, 169608