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High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339088
Recruitment Status : Not yet recruiting
First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:
The aim of the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the Sonovein® device. The quality of life scores at baseline, 2 weeks, 3 months, 6 months and 12 months will be assessed using the EQ-50D, AVVQ and CIVIQ scores. Patient satisfaction at these time points will also be assessed.

Condition or disease Intervention/treatment
Varicose Veins Venous Reflux Chronic Venous Insufficiency Other: Questionnaires

Detailed Description:
Sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. The high-intensity ultrasound beam is focused on the vein through a magnifying glass. As thermal energy is delivered, the thermocoagulation property of ultrasound energy affects the vein wall, causng shrinking and collapsing of the target vein. Thus creating a fibrotic seal and occluding the vessel. The treated vein is immediately closed after the procedure, and its diameter will continuously reduce over time, becoming a fibrotic chord. The treatment along the vein is steered automatically via a touch screen monitor. In-beam linear ultrasound probe allows visualisation of the vein in real-time and insures optimal accuracy. The study involves prospective data collection of 30 patients that will be undergoing HIFU as choice of treatment for their varicose veins / CVI. Questionnaires will be conducted at 5 timepoints - baseline before procedure, 2 weeks, 3 months, 6 months and 12 months. Subjects will be seen at outpatient clinic post-procedure. Besides questionnaires, physical examination and duplex ultrasound scan will be conducted at 2 weeks, 3 months, 6 months and 12 months to ensure occlusion of treated vein.

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HIFU
Patients that have undergone high focused ultrasound treatment for varicose veins
Other: Questionnaires
Questionnaires to assess quality of life




Primary Outcome Measures :
  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, 12 months post-procedure ]
    Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. Pain Score [ Time Frame: First 10 days post-procedure ]
    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-operation ]
  7. 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

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study involves prospective data collection of 30 patients that will be undergoing HIFU as a choice of treatment for their varicose veins / CVI.
Criteria

Inclusion Criteria:

  1. Age >21 years, able to understand the requirements of the study and provide informed consent.
  2. C2 - C5 varicose veins / CVI
  3. 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.
  4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion Criteria:

  1. Current DVT or history of DVT
  2. Recurrent varicose veins
  3. Pregnant patients
  4. Arterial disease (ABPI<0.8)
  5. Sepsis
  6. Patients who are unwilling to participate
  7. Inability or unwillingness to complete questionnaires
  8. Adverse reaction to sclerosant or cyanoacrylate
  9. GSV, SSV or AASV severely tortuous
  10. Life expectancy < 1 year
  11. Active treatment for malignancy other than non-melanoma skin cancer
  12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
  13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease

Information from the National Library of Medicine

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


Contacts
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Contact: Charyl Yap 65767986 charyl.yap.j.q@sgh.com.sg

Locations
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Singapore
Singapre General Hospital
Singapore, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Tjun Yip Tang Singapore General Hospital
  Study Documents (Full-Text)

Documents provided by Singapore General Hospital:
Study Protocol  [PDF] November 29, 2019
Informed Consent Form  [PDF] November 29, 2019

Publications:
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04339088    
Other Study ID Numbers: 2019/2933
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Endovenous Ablation
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Vascular Diseases
Cardiovascular Diseases