A Singapore Venaseal Real World Post-Market Evaluation Study (ASVS)

March 17, 2020 updated by: Singapore General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who will be undergoing Venaseal™ as treatment for their varicose veins / chronic venous insufficiency

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Venaseal
Patients that have undergone venaseal
Other: Questionnaires
Questionnaires to assess quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success at time of procedure
Time Frame: Immediately post-op
Occlusion of treated vein post-procedure
Immediately post-op
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
2 weeks, 3 months, 6 months and 12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken to return to work and normal activities
Time Frame: 10 days post-op
10 days post-op
Quality of Life Score using the EQ-5D questionnaire
Time Frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
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.
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
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.
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
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
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
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).
Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation
Pain Score
Time Frame: First 10 days post-operation
Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
First 10 days post-operation
Occlusion rates
Time Frame: 2 weeks, 3 months, 6 months and 12 months post-operation
Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
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
A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure.
2 weeks, 3 months, 6 months and 12 months post-procedure
Cost Effectiveness of the intervention
Time Frame: 12 months post-procedure
To evaluate the cost involved with procedure performed
12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2018

Primary Completion (ACTUAL)

January 31, 2020

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (ACTUAL)

March 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/2087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Varicose Veins

Clinical Trials on Questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe