Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (VERITAS)

March 2, 2026 updated by: Boston Scientific Corporation

A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein

The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein.

Study Overview

Status

Status

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

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

To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes.

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.
Interventional

Enrollment (Actual)

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.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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 Contact Backup

Study Locations

  • United States
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Vascular Care Connecticut
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20057
        • MedStar Georgetown University Hospital
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
    • Maine
      • South Portland, Maine, United States, 04106
        • Vein Healthcare Center
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • UT Physicians Cardiothoracic and Vascular Surgery
    • Washington
      • Bellevue, Washington, United States, 98004
        • Lake Washington Vascular

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18
  • Primary GSV incompetence, defined as reflux > 0.5 seconds on Duplex ultrasound in a single limb (Note the contralateral limb can have varicosities or SVI if intervention is not required within 3 months i.e. asymptomatic)
  • Failed conservative therapy (compression, diet, exercise, leg elevation)
  • CEAP Clinical Condition Classification C2 - C6
  • Vein diameter 5-10mm, inclusive
  • GSV treatable length > 10cm
  • Superficial venous disease manifest by clinical symptoms (rVCSS ≥ 4)
  • Able to comprehend and sign an informed consent document and complete written study questionnaires
  • Willing and able to return for scheduled follow-up visits (7-days, 3-months, 6-months, 12-months, 24-months, and 36-months post-procedure)
  • Willingness to comply with post-treatment compression protocol

Exclusion Criteria:

  • Allergy to polidocanol, xylocaine, or epinephrine
  • Deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or hypercoagulable disorder
  • Post thrombotic deep vein disease above the calf veins
  • Pregnancy or lactating (within 30 days of randomization)
  • Symptomatic peripheral arterial disease or ankle-brachial pressure index (ABPI) < 0.8
  • Previous treatment to targeted incompetent GSV or previous superficial thrombophlebitis in targeted GSV
  • Previous venous intervention in affected limb in past 3 months
  • Local aneurysmal GSV segments
  • Inability to walk unaided
  • Inability to wear post-procedure compression bandaging and stockings
  • Patients with clinically significant reflux of the small saphenous vein (SSV) or anterior accessory saphenous vein (AASV)
  • In the clinical judgement of the investigator, patient who will require ipsilateral deep venous intervention within 3 months following randomized treatment
  • In the clinical judgement of the investigator, patient who will require contralateral venous intervention (superficial or deep) within 3 months following randomized treatment
  • Patient on therapeutic anticoagulants
  • Active malignancy
  • Life expectancy < 2 years
  • Documented COVID-19 infection currently or within 2 months prior to randomization
  • Enrollment in another clinical trial that could confound the endpoint within 3 months prior to screening or within 3 months following enrollment

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Varithena®
Varithena® (polidocanol injectable foam) 1%
Drug: Varithena®
Varithena® (polidocanol injectable foam) 1%
Active Comparator: FDA-approved ETA systems
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
Device: FDA-approved Endothermal Ablation (ETA) systems
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

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
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
Time Frame: Baseline to 3-month post treatment
Mean change in points of total score on Varicose Veins Symptoms Questionnaire (VVSymQ) between baseline and 3-month post treatment. VVSymQ scores range from 0 to 25, where 0 represents no symptoms and 25 represents all 5 symptoms experienced all of the time.
Baseline to 3-month post treatment

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.
Boston Scientific Corporation

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.
February 10, 2023

Primary Completion (Actual)

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.
April 4, 2024

Study Completion (Actual)

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.
April 4, 2024

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).
March 29, 2022

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.
March 29, 2022

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.
April 6, 2022

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.
March 20, 2026

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.
March 2, 2026

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.
January 1, 2026

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.
  • S2473

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

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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