High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)
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|ClinicalTrials.gov Identifier: NCT04339088|
Recruitment Status : Not yet recruiting
First Posted : April 9, 2020
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment|
|Varicose Veins Venous Reflux Chronic Venous Insufficiency||Other: Questionnaires|
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||Pilot Study to InVestigate the Efficacy and Safety of High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
Patients that have undergone high focused ultrasound treatment for varicose veins
Questionnaires to assess quality of life
- Technical success at time of procedure [ Time Frame: Immediately post-op ]Occlusion of treated vein post-procedure
- Change in anatomy of treated vessel [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein.
- Quality of life score using EQ-5D questionnaire [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]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) [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]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) [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]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 using Venous Clinical Severity Score (VCSS) [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).
- Pain Score [ Time Frame: First 10 days post-procedure ]Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
- Time taken to return to work and normal activities [ Time Frame: 10 days post-operation ]
- Occlusion rates [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
- Patient satisfaction with treatment [ Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure ]A short survey to assess patient satisfaction and if there is any observed improvement in terms of appearance and symptoms post-procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339088
|Contact: Charyl Yapfirstname.lastname@example.org|
|Singapre General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Tjun Yip Tang||Singapore General Hospital|