A Singapore Venaseal Real World Post-Market Evaluation Study

Completed

• Conditions: Varicose Veins; Chronic Venous Insufficiency; Venous Reflux
• Interventions: Other: Questionnaires

• Registration Number: NCT03893201
• Lead Sponsor: Singapore General Hospital

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.

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Venaseal	Questionnaires	Patients that have undergone venaseal

Primary Outcome Measures

Name	Time	Method
Technical Success at time of procedure	Immediately post-op	Occlusion of treated vein post-procedure
Change in anatomy of treated vessel	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 Outcome Measures

Name	Time	Method
Quality of Life Score using the EQ-5D questionnaire	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.
Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)	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.
Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)	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
Clinical Change usin Venous Clinical Severity Score (VCSS)	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).
Pain Score	First 10 days post-operation	Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
Time taken to return to work and normal activities	10 days post-op
Occlusion rates	2 weeks, 3 months, 6 months and 12 months post-operation	Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
Patient satisfaction with treatment	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.
Cost Effectiveness of the intervention	12 months post-procedure	To evaluate the cost involved with procedure performed

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Sengkang General Hospital; 🇸🇬 Singapore, Singapore