AzTrials
AzTrials

Varicose VeinsESVSNCT04384315

Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux. Read more about this study

Who is it for?
Ages 21 to 90 years
What is being tested?
Questionnaires
How many people
30 participants
Where
1 siteSingapore
Study dates
1 Aug 2019to 1 Dec 2022
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
  • Adult, Older adult

Study population: Patients who will be undergoing Endovenous Radio Frequency® (EVRF®) as a treatment for their varicose veins / chronic venous insufficiency

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 primaryGSV, 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, 1 recruiting

  • Singapre General Hospital

    Singapore, Singaopore, 169608

    Charyl Yap, 65767986, charyl.yap.j.q@sgh.com.sg

    Tjun Yip Tang

    Recruiting

Other trials in Singapore

About this study

Official title: Pilot Study to Investigate the Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore

The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

Read the detailed description

The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months.

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 the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)

Study groups in NCT04384315
Study groupRoleWhat they receive
EVRFPatients that have undergone Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.
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-procedure

  2. Anatomical Success

    Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound.

    Measured: 2 weeks to 12 months post-procedure

Secondary outcomes (8)

  1. 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.

    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-operation

  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: survey

    A short survey to assess patient satisfaction and if there are 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 posted12 May 2020
  2. Study start1 Aug 2019
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Dec 2022 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04384315
Sponsor's protocol ID
2019/2544
Acronym
ESVS
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

  • Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

    PubMed 21536172

  • Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.

    PubMed 15723761

  • van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.

    PubMed 18692348

  • Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.

  • van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins--a review of literature. Semin Vasc Surg. 2014 Jun;27(2):118-36. doi: 10.1053/j.semvascsurg.2015.02.002. Epub 2015 Feb 18.

    PubMed 25868763

  • Guex JJ. Endovenous chemical (and physical) treatments for varices: what's new? Phlebology. 2014 May;29(1 suppl):45-48. doi: 10.1177/0268355514526331. Epub 2014 May 19.

    PubMed 24843085

  • Davies HO, Popplewell M, Darvall K, Bate G, Bradbury AW. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology. 2016 May;31(4):234-40. doi: 10.1177/0268355515595194. Epub 2015 Jul 9.

    PubMed 26163507

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-procedure). 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 NCT04384315, which also lists 7 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in