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

October 29, 2020 updated by: Singapore General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

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
        • Singapre 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 Venablock© as a treatment for their varicose veins / chronic venous insufficiency

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current DVT or history of DVT
  2. Pregnant patients
  3. Arterial disease (ABPI<0.8)
  4. Sepsis
  5. Patient who are unwilling to participate
  6. Inability or unwillingness to complete the time-point questionnaires
  7. Adverse reaction to sclerosant or cyanoacrylate previously
  8. Multiple drug allergies
  9. Previous intervention with the VenaSeal cyanoacrylate glue closure system
  10. Severely tortuous GSV, SSV or AASV
  11. Life expectancy < 1 year
  12. Active treatment for malignancy other than non-melanoma skin cancer
  13. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
  14. 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
Venablock
Patients that have undergone Venablock treatment
Other: Questionnaires
Questionnaires to access the quality of life (EQ5D, VCSS, CVVQ, CIVIQ, Patient satisfaction survey)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusion of treated vein post-procedure
Time Frame: Immediately post-op
Immediately post-op
Change in anatomy of treated vessel
Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
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.
2 weeks, 3 months, 6 months, 12 months post-procedure
Clinical Change using Venous Clinical Severity Score (VCSS)
Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).
2 weeks, 3 months, 6 months, 12 months post-procedure
Pain Score
Time Frame: First 10 days post-procedure
Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)
First 10 days post-procedure
Occlusion rates
Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded
2 weeks, 3 months, 6 months, 12 months post-procedure
Quality of Life Score using the EQ-5D questionnaire
Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
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.
2 weeks, 3 months, 6 months, 12 months post-procedure
Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)
Time Frame: 2 weeks, 3 months, 6 months, 12 months post-procedure
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.
2 weeks, 3 months, 6 months, 12 months post-procedure
Time taken to return to work and normal activities
Time Frame: Recorded 10 days post-procedure
Recorded 10 days post-procedure
Patient satisfaction with treatment: survey
Time Frame: 2 weeks, 3 months, 6 months, 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. Options range from highly unsatisfied to highly satisfied.
2 weeks, 3 months, 6 months, 12 months post-procedure
Cost effectiveness of the intervention
Time Frame: 12 months post-procedure
to evaluate the cost involved with the 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

Investigators

  • Principal Investigator: Turn Yip Tang, 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)

October 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 8, 2020

First Posted (ACTUAL)

April 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/2749

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.

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