NCT04339088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

April 6, 2020

Last Update Submit

September 23, 2021

Conditions

Varicose VeinsVenous RefluxChronic Venous Insufficiency

Keywords

Endovenous Ablation

Outcome Measures

Primary Outcomes (2)

  • Technical success at time of procedure

    Occlusion of treated vein post-procedure

    Immediately post-op

  • Change in anatomy of treated vessel

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

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

Secondary Outcomes (8)

  • Quality of life score using EQ-5D questionnaire

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

  • Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)

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

  • Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)

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

  • Clinical Change using Venous Clinical Severity Score (VCSS)

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

  • Pain Score

    First 10 days post-procedure

  • +3 more secondary outcomes

Study Arms (1)

HIFU

Patients that have undergone high focused ultrasound treatment for varicose veins

Other: Questionnaires

Interventions

QuestionnairesOTHER

Questionnaires to assess quality of life

HIFU

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapre General Hospital

Singapore, 169608, Singapore

Location

Related Publications (8)

  • 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.

    PMID: 12651169BACKGROUND

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

    PMID: 8156326BACKGROUND

  • 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.

    PMID: 19551312BACKGROUND

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

    PMID: 12934754BACKGROUND

  • 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.

    PMID: 11207682BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 15364562BACKGROUND

  • 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.

    PMID: 19879166BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Tjun Yip Tang

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap

CONTACT

65767986charyl.yap.j.q@sgh.com.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 9, 2020

Study Start

March 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)