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Varicose VeinsVESPANCT04339088

High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore

An observational study of Varicose Veins and Venous Reflux, run by Singapore General Hospital at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years
What is being tested?
Questionnaires
How many people
15 participants
Where
1 siteSingapore
Study dates
1 Mar 2022to 1 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Current DVT or history of DVT
  • Recurrent varicose veins
  • Pregnant patients
  • Arterial disease (ABPI<0.8)
  • Sepsis
  • Patients who are unwilling to participate
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Charyl Yap contact

65767986

charyl.yap.j.q@sgh.com.sg

Singapore1 site

  • Singapre General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

Official title: Pilot Study to InVestigate the Efficacy and Safety of High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore (VESPA)

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.

Read the 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, causing 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.

Being tested
Questionnaires
Keywords
Endovenous Ablation
Medical subject headings
Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

    Questionnaires to assess quality of life

Study groups in NCT04339088
Study groupRoleWhat they receive
HIFUPatients that have undergone high focused ultrasound treatment for varicose veins
Receives: Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical success at time of procedure

    Occlusion of treated vein post-procedure

    Measured: Immediately post-op

  2. Change in anatomy of treated vessel

    Anatomical success as measured at each time-point using ultrasound to ensure occlusion of treated vein.

    Measured: 2 weeks, 3 months, 6 months, 12 months post-procedure

Secondary outcomes (8)

  1. Quality of life score using 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.

    Measured: 2 weeks, 3 months, 6 months, 12 months post-procedure

  2. 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.

    Measured: 2 weeks, 3 months, 6 months, 12 months post-procedure

  3. 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

    Measured: 2 weeks, 3 months, 6 months, 12 months post-procedure

  4. Clinical Change using Venous Clinical Severity Score (VCSS)

    VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).

    Measured: 2 weeks, 3 months, 6 months, 12 months post-procedure

  5. Pain Score

    Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)

    Measured: First 10 days post-procedure

  6. Time taken to return to work and normal activities

    Measured: 10 days post-operation

  7. Occlusion rates

    Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded

    Measured: 2 weeks, 3 months, 6 months, 12 months post-procedure

  8. Patient satisfaction with treatment

    A short survey to assess patient satisfaction and if there is any observed improvement in terms of appearance and symptoms post-procedure.

    Measured: 2 weeks, 3 months, 6 months, 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2020
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04339088
Sponsor's protocol ID
2019/2933
Acronym
VESPA
Status last verified
Sep 2021
First submitted
6 Apr 2020
Last updated
27 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Golledge J, Quigley FG. Pathogenesis of varicose veins. Eur J Vasc Endovasc Surg. 2003 Apr;25(4):319-24. doi: 10.1053/ejvs.2002.1843.

    PubMed 12651169

  • Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204.

    PubMed 8156326

  • Tan KK, Nalachandran S, Chia KH. Endovenous laser treatment for varicose veins in Singapore: a single centre experience of 169 patients over two years. Singapore Med J. 2009 Jun;50(6):591-4.

    PubMed 19551312

  • Jawien A. The influence of environmental factors in chronic venous insufficiency. Angiology. 2003 Jul-Aug;54 Suppl 1:S19-31. doi: 10.1177/0003319703054001S04.

    PubMed 12934754

  • Navarro L, Min RJ, Bone C. Endovenous laser: a new minimally invasive method of treatment for varicose veins--preliminary observations using an 810 nm diode laser. Dermatol Surg. 2001 Feb;27(2):117-22. doi: 10.1046/j.1524-4725.2001.00134.x.

    PubMed 11207682

  • Law, Y., Chan, Y. C., Cheung, G. C. Y., Ting, A. C. W., Wong, A. C. C., & Cheng, S. W. K. (2016). Early single-centre comparative results on non-thermal ablation of symptomatic incompetent great saphenous veins (GSV): cyanoacrylate glue (VenaSeal) versus mechanicochemical ablation (ClariVein). Leipzig Interventional Course, LINC 2016.

  • Teruya TH, Ballard JL. New approaches for the treatment of varicose veins. Surg Clin North Am. 2004 Oct;84(5):1397-417, viii-ix. doi: 10.1016/j.suc.2004.04.008.

    PubMed 15364562

  • Subramonia S, Lees T. Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial. Eur J Vasc Endovasc Surg. 2010 Jan;39(1):104-11. doi: 10.1016/j.ejvs.2009.09.012. Epub 2009 Oct 29.

    PubMed 19879166

Questions about this trial

What is this clinical trial studying?

An observational study of Varicose Veins and Venous Reflux, run by Singapore General Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Charyl Yap (65767986, charyl.yap.j.q@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success at time of procedure (time frame: Immediately post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04339088, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.

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