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Varicose VeinsRIVIERANCT04339075

Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To assess the efficacy of the Venablock©Vein Sealing System (VBVS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting in a multi-racial Asian population in Singapore. 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 Oct 2019to 1 Oct 2021
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 Venablock© as a treatment for their varicose veins / chronic venous insufficiency

Who may be able to join

  • Age > 21 years old and ability to understand the requirements of the study and to provide informed consent
  • C2-C6 varicose veins/CVI (CEAP Class 1 patients will be excluded)
  • 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 had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position

Who cannot join

  • Current DVT or history of DVT
  • Pregnant patients
  • Arterial disease (ABPI<0.8)
  • Sepsis
  • Patient who are unwilling to participate
  • Inability or unwillingness to complete the time-point questionnaires
Show all 14Show fewer
  • Adverse reaction to sclerosant or cyanoacrylate previously
  • Multiple drug allergies
  • Previous intervention with the VenaSeal cyanoacrylate glue closure system
  • Severely tortuous GSV, SSV or AASV
  • 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.

Singapore1 site

  • Singapre General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

To assess the efficacy of the Venablock©Vein Sealing System (VBVS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting in a multi-racial Asian population in Singapore.

Read the detailed description

The purpose of the Registry to Investigate the Efficacy and Safety of Venablock©Vein Sealing System for Varicose Veins in Singapore (RIVERIA), is to investigate the performance of cyanoacrylate glue closure (CAC) using this device, in which multiple incompetent superficial saphenous truncal veins (great saphenous (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) will be treated at the same setting, and compression stockings will not be used post-operatively. The inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such,RIVIERA will be the first prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of Venablock© for blocking incompetent truncal veins. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion, and patient experience after treatment with Venablock© with broader inclusion of patients than previous caucasian based trials.

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 access the quality of life (EQ5D, VCSS, CVVQ, CIVIQ, Patient satisfaction survey)

Study groups in NCT04339075
Study groupRoleWhat they receive
VenablockPatients that have undergone Venablock treatment
Receives: Other: Questionnaires

What is being measured

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

  1. Occlusion of treated vein post-procedure

    Measured: Immediately post-op

  2. Change in anatomy of treated vessel

    Anatomical Success as measured at each timepoint using ultrasound to ensure occlusion of treated vessel. Recurrence or treatment failure will be defined as a re-opening of a segment > 5cm in length.

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

Secondary outcomes (9)

  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. The higher the score, the better the quality of life is.

    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: Recorded 10 days post-procedure

  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. Options range from highly unsatisfied to highly satisfied.

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

  9. Cost effectiveness of the intervention

    to evaluate the cost involved with the procedure performed

    Measured: 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 Oct 2019
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completion1 Oct 2021 (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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04339075
Sponsor's protocol ID
2019/2749
Acronym
RIVIERA
Status last verified
Oct 2020
First submitted
6 Apr 2020
Last updated
2 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev. 2014 Jul 30;(7):CD005624. doi: 10.1002/14651858.CD005624.pub3.

    PubMed 25075589

  • Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.

    PubMed 22705163

  • Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg. 2008 Mar;95(3):294-301. doi: 10.1002/bjs.6101.

    PubMed 18278775

  • Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555.

    PubMed 21725957

  • Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. No abstract available.

    PubMed 23884969

  • Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH. Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins. Br J Surg. 2010 Jun;97(6):810-8. doi: 10.1002/bjs.7091.

    PubMed 20473992

  • Shepherd AC, Gohel MS, Lim CS, Hamish M, Davies AH. Pain following 980-nm endovenous laser ablation and segmental radiofrequency ablation for varicose veins: a prospective observational study. Vasc Endovascular Surg. 2010 Apr;44(3):212-6. doi: 10.1177/1538574409359337. Epub 2010 Feb 11.

    PubMed 20150227

  • Rabe E, Otto J, Schliephake D, Pannier F. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg. 2008 Feb;35(2):238-45. doi: 10.1016/j.ejvs.2007.09.006. Epub 2007 Nov 7.

    PubMed 17988905

  • Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.

    PubMed 25650040

  • Tang TY, Kam JW, Gaunt ME. ClariVein(R) - Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins. Phlebology. 2017 Feb;32(1):6-12. doi: 10.1177/0268355516630154. Epub 2016 Jul 9.

    PubMed 26908638

  • Vanlangenhove P, De Keukeleire K, Everaert K, Van Maele G, Defreyne L. Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study. Cardiovasc Intervent Radiol. 2012 Jun;35(3):598-606. doi: 10.1007/s00270-011-0188-9. Epub 2011 Jun 3.

    PubMed 21638147

  • Brothers MF, Kaufmann JC, Fox AJ, Deveikis JP. n-Butyl 2-cyanoacrylate--substitute for IBCA in interventional neuroradiology: histopathologic and polymerization time studies. AJNR Am J Neuroradiol. 1989 Jul-Aug;10(4):777-86.

    PubMed 2505505

  • Ovali C, Sevin MB. Twelve-month efficacy and complications of cyanoacrylate embolization compared with radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2019 Mar;7(2):210-216. doi: 10.1016/j.jvsv.2018.10.019. Epub 2019 Jan 14.

    PubMed 30655108

  • Yavuz T, Acar AN, Aydin H, Ekingen E. A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results. Vascular. 2018 Oct;26(5):547-555. doi: 10.1177/1708538118770548. Epub 2018 Apr 11.

    PubMed 29642798

  • Lee Q, Gibson K, Chan SL, Rathnaweera HP, Chong TT, Tang TY. A comparison between Caucasian and Asian superficial venous anatomy and reflux patterns - Implications for potential precision endovenous ablation therapy. Phlebology. 2020 Feb;35(1):39-45. doi: 10.1177/0268355519845984. Epub 2019 Apr 29. No abstract available.

    PubMed 31032714

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 14 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 2 Nov 2020. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occlusion of treated vein post-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 NCT04339075, which also lists 15 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 2 Nov 2020.

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