A Singapore Venaseal Real World Post-Market Evaluation Study

NCT03893201 | Completed

• 1 other identifier: 2017/2087
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to assess the efficacy of VenaSeal™ Closure System (VCS) 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)

• 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 timepoint using ultrasound to ensure no re-opening of treated vessel

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

Secondary Outcomes (9)

• Quality of Life Score using the EQ-5D questionnaire

  Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

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

  Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

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

  Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

• Clinical Change usin Venous Clinical Severity Score (VCSS)

  Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

• Pain Score

  First 10 days post-operation

Study Arms (1)

Venaseal

Patients that have undergone venaseal

Other: Questionnaires

Interventions

Questionnaires OTHER

Questionnaires to assess quality of life

Venaseal

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 Venaseal™ as treatment for their varicose veins / chronic venous insufficiency

You may qualify if:

• Age \> 21 years old and able to understand the requirements of the study and to provide informed consent
• C2 - C5 symptomatic veins / Chronic Venous Insufficiency
• 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
• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Sengkang General Hospital

Singapore, 544886, Singapore

Location

Related Publications (13)

• 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

• 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

• Tang TY, Yap CJQ, Chan SL, Soon SXY, Khoo VBX, Choke E, Chong TT. 3-year clinical outcomes of A Singapore VenaSeal real world post-market evaluation Study (ASVS) for varicose vein ablation. CVIR Endovasc. 2024 Apr 27;7(1):41. doi: 10.1186/s42155-024-00452-8.

  PMID: 38676860 DERIVED

• Tang TY, Yap CJQ, Chan SL, Soon SXY, Yap HY, Lee SQW, Choke ETC, Chong TT. Early results of an Asian prospective multicenter VenaSeal real-world postmarket evaluation to investigate the efficacy and safety of cyanoacrylate endovenous ablation for varicose veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):335-345.e2. doi: 10.1016/j.jvsv.2020.03.020. Epub 2020 May 7.

  PMID: 32387378 DERIVED

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

• Tjun 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: March 4, 2019
• First Posted: March 28, 2019
• Study Start: April 11, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)