Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore (ESVS)

September 23, 2021 updated by: Singapore General Hospital

Pilot Study to Investigate the Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore

The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
    • Singaopore
      • Singapore, Singaopore, Singapore, 169608
        • Recruiting
        • Singapre General Hospital
        • Principal Investigator:
          • Tjun Yip Tang
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 Endovenous Radio Frequency® (EVRF®) as a treatment for their varicose veins / chronic venous insufficiency

Description

Inclusion Criteria:

  1. Age >21 years, able to understand the requirements of the study and provide informed consent.
  2. C2 - C5 varicose veins / CVI
  3. Symptomatic primaryGSV, 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 has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion Criteria:

  1. Current DVT or history of DVT
  2. Recurrent varicose veins
  3. Pregnant patients
  4. Arterial disease (ABPI<0.8)
  5. Sepsis
  6. Patients who are unwilling to participate
  7. Inability or unwillingness to complete questionnaires
  8. Adverse reaction to sclerosant or cyanoacrylate
  9. GSV, SSV or AASV severely tortuous
  10. Life expectancy < 1 year
  11. Active treatment for malignancy other than non-melanoma skin cancer
  12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
  13. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EVRF
Patients that have undergone Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.
Other: Questionnaires
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Technical Success at time of procedure
Time Frame: Immediately post-procedure
Occlusion of treated vein post-procedure
Immediately post-procedure
Anatomical Success
Time Frame: 2 weeks to 12 months post-procedure
Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound.
2 weeks to 12 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
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
Time taken to return to work and normal activities
Time Frame: 10 days post-operation
10 days post-operation
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
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
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.
2 weeks, 3 months, 6 months, 12 months 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.
2 weeks, 3 months, 6 months, 12 months post-procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019/2544

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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