Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore

NCT04339075 | Unknown

• 1 other identifier: 2019/2749
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicose Veins; Venous Reflux; Chronic Venous Insufficiency

Keywords

Endovenous Ablation

Outcome Measures

Primary Outcomes (2)

• Occlusion of treated vein post-procedure

  Immediately post-op

• 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.

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

Secondary Outcomes (9)

• Quality of Life Score using the 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

Study Arms (1)

Venablock

Patients that have undergone Venablock treatment

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Venablock

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will be undergoing Venablock© as a treatment for their varicose veins / chronic venous insufficiency

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapre General Hospital

Singapore, 169608, Singapore

Location

Related Publications (15)

• 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.

  PMID: 25075589 BACKGROUND

• 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.

  PMID: 22705163 BACKGROUND

• 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.

  PMID: 18278775 BACKGROUND

• 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.

  PMID: 21725957 BACKGROUND

• 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.

  PMID: 23884969 BACKGROUND

• 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.

  PMID: 20473992 BACKGROUND

• 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.

  PMID: 20150227 BACKGROUND

• 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.

  PMID: 17988905 BACKGROUND

• 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.

  PMID: 25650040 BACKGROUND

• 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.

  PMID: 26908638 BACKGROUND

• 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.

  PMID: 21638147 BACKGROUND

• 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.

  PMID: 2505505 BACKGROUND

• 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.

  PMID: 30655108 BACKGROUND

• 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.

  PMID: 29642798 BACKGROUND

• 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.

  PMID: 31032714 BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Turn Yip Tang

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

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: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)