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Completed

NCT Number: NCT03893201

A Singapore Venaseal Real World Post-Market Evaluation Study

The study aims to assess the efficacy of VenaSeal™ Closure System (VCS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting, in a multi-racial Asian population in Singapore.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Chronic Venous Insufficiency Vascular Diseases Venous Reflux

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sengkang General Hospital, Singapore

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About this study

The purpose of the ASVS study is to investigate the performance of cyanoacrylate glue closure (CAC) in a real-world post market evaluation setting in which multiple incompetent superficial saphenous truncal veins - namely (great saphenous vein (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) - will be treated at the same setting, and compression stockings will not be used postoperatively. Unlike previous studies, the inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such, ASVS will be the first published prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of CAC for incompetent GSV and non-GSV trunks. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion and patient experience with CAC applied with broader inclusion of patients than previous trials.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 21 years old and able to understand the requirements of the study and to provide informed consent
  • C2 - C5 symptomatic veins / Chronic Venous Insufficiency
  • 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 criteria

  • 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

Treatment and study plan

questionnaires

Other

Questionnaires to assess quality of life

Primary outcomes

  1. Technical Success at time of procedure

    Time frame: Immediately post-op

    Occlusion of treated vein post-procedure

  2. Change in anatomy of treated vessel

    Time frame: 2 weeks, 3 months, 6 months and 12 months post-procedure

    Anatomical Success as measured at each timepoint using ultrasound to ensure no re-opening of treated vessel

Secondary outcomes

  1. Quality of Life Score using the EQ-5D questionnaire

    Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

    EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime.

  2. Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)

    Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

    CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life.

  3. Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)

    Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

    To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life

  4. Clinical Change usin Venous Clinical Severity Score (VCSS)

    Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

    VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).

  5. Pain Score

    Time frame: First 10 days post-operation

    Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)

  6. Time taken to return to work and normal activities

    Time frame: 10 days post-op

  7. Occlusion rates

    Time frame: 2 weeks, 3 months, 6 months and 12 months post-operation

    Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded

  8. Patient satisfaction with treatment

    Time frame: 2 weeks, 3 months, 6 months and 12 months post-procedure

    A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure.

  9. Cost Effectiveness of the intervention

    Time frame: 12 months post-procedure

    To evaluate the cost involved with procedure performed

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore

Acronym: ASVS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 28, 2019
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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