Varicose VeinsASVSNCT03893201

A Singapore Venaseal Real World Post-Market Evaluation Study

An observational study of Varicose Veins and Venous Reflux, run by Singapore General Hospital at 2 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 21 to 90 years
Conditions the study is for: Varicose Veins, Venous Reflux, Chronic Venous Insufficiency
What is being tested?: Questionnaires
How many people: 100 participants
Where: 2 sitesSingapore
Study dates: 11 Apr 2018to 31 Jan 2020
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 Venaseal™ as treatment for their varicose veins / chronic venous insufficiency

Who may be able to join

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

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

2 sites in 1 country.

Singapore2 sites

Singapore General Hospital
Singapore, 169608
Sengkang General Hospital
Singapore, 544886

Other trials in Singapore

About this study

Official title: Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore

Read the detailed description

The purpose of the ASVS study is to investigate the performance of cyanoacrylate glue closure (CAC) in a real-world post market evaluation setting in which multiple incompetent superficial saphenous truncal veins - namely (great saphenous vein (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) - will be treated at the same setting, and compression stockings will not be used postoperatively. Unlike previous studies, the inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such, ASVS will be the first published prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of CAC for incompetent GSV and non-GSV trunks. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion and patient experience with CAC applied with broader inclusion of patients than previous trials.

Conditions: Varicose Veins, Venous Reflux, Chronic Venous Insufficiency
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 quality of life

Study groups in NCT03893201
Study group	Role	What they receive
Venaseal		Patients that have undergone venaseal Receives: Other: Questionnaires

What is being measured

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

Technical Success at time of procedure
Occlusion of treated vein post-procedure
Measured: 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
Measured: 2 weeks, 3 months, 6 months and 12 months post-procedure

Secondary outcomes (9)

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: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
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: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
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: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
Clinical Change usin Venous Clinical Severity Score (VCSS)
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).
Measured: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
Pain Score
Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
Measured: First 10 days post-operation
Time taken to return to work and normal activities
Measured: 10 days post-op
Occlusion rates
Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
Measured: 2 weeks, 3 months, 6 months and 12 months post-operation
Patient satisfaction with treatment
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 and 12 months post-procedure
Cost Effectiveness of the intervention
To evaluate the cost involved with 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.

11 Apr 201831 Jan 2020

First posted28 Mar 2019
Study start11 Apr 2018
Primary completion31 Jan 2020
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Varicose VeinsStudies of the same condition, open and under way.
More trials run by Singapore General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03893201
Sponsor's protocol ID: 2017/2087
Acronym: ASVS
Status last verified: Mar 2020
First submitted: 4 Mar 2019
Last updated: 18 Mar 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
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
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.
PubMed 38676860
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.
PubMed 32387378

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore
ClinicalTrials.gov ID: NCT03893201
Acronym / sponsor ID: ASVS / 2017/2087
Conditions: Varicose Veins, Venous Reflux, Chronic Venous Insufficiency
Keywords: Endovenous Ablation
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Singapore General HospitalUniversity, hospital or other
Study start: 11 Apr 2018 (actual)
Primary completion: 31 Jan 2020 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 28 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Venaseal	–	Other: QuestionnairesPatients that have undergone venaseal

Who may qualify

Ages: 21 to 90 years
Sex: All
Age groups: Adult, Older adult
Study population: Patients who will be undergoing Venaseal™ as treatment for their varicose veins / chronic venous insufficiency

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

Current DVT or history of DVT
Recurrent varicose veins
Pregnant patients
Arterial Disease (ABPI<0.8)
Sepsis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QuestionnairesQuestionnaires to assess quality of life	Other	Venaseal

Primary outcome

Technical Success at time of procedure
Time frame: Immediately post-op
Occlusion of treated vein post-procedure
Change in anatomy of treated vessel
Time frame: 2 weeks, 3 months, 6 months and 12 months post-procedure
Anatomical Success as measured at each timepoint using ultrasound to ensure no re-opening of treated vessel

9 secondary outcomes

Quality of Life Score using the EQ-5D questionnaire
Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
Clinical Change usin Venous Clinical Severity Score (VCSS)
Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
Pain Score
Time frame: First 10 days post-operation
Time taken to return to work and normal activities
Time frame: 10 days post-op
Occlusion rates
Time frame: 2 weeks, 3 months, 6 months and 12 months post-operation
Patient satisfaction with treatment
Time frame: 2 weeks, 3 months, 6 months and 12 months post-procedure
Cost Effectiveness of the intervention
Time frame: 12 months post-procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Background: PubMed 25075589Nesbitt 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.
Background: PubMed 22705163Siribumrungwong 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.
Background: PubMed 18278775Darwood 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.
Background: PubMed 21725957Rasmussen 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.
Background: PubMed 23884969Marsden 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.
Background: PubMed 20473992Shepherd 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.
Background: PubMed 17988905Rabe 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.
Background: PubMed 25650040Morrison 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.
Background: PubMed 26908638Tang 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.
Background: PubMed 21638147Vanlangenhove 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.
Background: PubMed 2505505Brothers 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.
Derived from this study: PubMed 38676860Tang 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tjun Yip Tang principal investigator

Singapore General Hospital

2 sites in 1 country: see every site and its status.

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 2 sites 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: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Technical Success at time of 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 NCT03893201, which also lists 13 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 18 Mar 2020.