Clinical trial NCT03893201: A Singapore Venaseal Real World Post-Market Evaluation Study
Official title: Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Venous Reflux
Chronic Venous Insufficiency
Keywords: Endovenous Ablation
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be undergoing Venaseal™ as treatment for their varicose veins / chronic venous insufficiency

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Technical Success at time of procedure
timeFrame: Immediately post-op
measure: Change in anatomy of treated vessel
timeFrame: 2 weeks, 3 months, 6 months and 12 months post-procedure
Secondary outcomes:
measure: Quality of Life Score using the EQ-5D questionnaire
timeFrame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
measure: Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
timeFrame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
measure: Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
measure: Clinical Change usin Venous Clinical Severity Score (VCSS)
timeFrame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
measure: Pain Score
timeFrame: First 10 days post-operation
measure: Time taken to return to work and normal activities
timeFrame: 10 days post-op
measure: Occlusion rates
timeFrame: 2 weeks, 3 months, 6 months and 12 months post-operation
measure: Patient satisfaction with treatment
timeFrame: 2 weeks, 3 months, 6 months and 12 months post-procedure
measure: Cost Effectiveness of the intervention
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Sengkang General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Tjun Yip Tang
role: PRINCIPAL_INVESTIGATOR
References:
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