Varicose Veins Clinical Trial
— ASVSOfficial title:
Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore
NCT number | NCT03893201 |
Other study ID # | 2017/2087 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 11, 2018 |
Est. completion date | January 31, 2020 |
Verified date | March 2020 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study aims to assess the efficacy of VenaSealâ„¢ 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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 31, 2020 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | Sengkang General Hospital | Singapore | |
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
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Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg. 2008 Mar;95(3):294-301. doi: 10.1002/bjs.6101. — View Citation
Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical Success at time of procedure | Occlusion of treated vein post-procedure | Immediately post-op | |
Primary | Change in anatomy of treated vessel | Anatomical Success as measured at each timepoint using ultrasound to ensure no re-opening of treated vessel | 2 weeks, 3 months, 6 months and 12 months post-procedure | |
Secondary | Quality of Life Score using the EQ-5D questionnaire | 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. | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | |
Secondary | Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) | 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. | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | |
Secondary | Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) | 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 | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | |
Secondary | Clinical Change usin Venous Clinical Severity Score (VCSS) | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe). | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | |
Secondary | Pain Score | Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain) | First 10 days post-operation | |
Secondary | Time taken to return to work and normal activities | 10 days post-op | ||
Secondary | Occlusion rates | Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded | 2 weeks, 3 months, 6 months and 12 months post-operation | |
Secondary | Patient satisfaction with treatment | A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure. | 2 weeks, 3 months, 6 months and 12 months post-procedure | |
Secondary | Cost Effectiveness of the intervention | To evaluate the cost involved with procedure performed | 12 months post-procedure |
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