Varicose VeinsPhase 4VERITASNCT05312970
Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
A Phase 4 study testing Varithena® and FDA-approved Endothermal Ablation (ETA) systems in people with Varicose Veins, run by Boston Scientific Corporation at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Varithena® and FDA-approved Endothermal Ablation (ETA) systems
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Feb 2023to 4 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Lake Washington Vascular
Bellevue, Washington, 98004
Vascular Care Connecticut
Darien, Connecticut, 06820
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Cardiovascular Institute of the South
Houma, Louisiana, 70360
UT Physicians Cardiothoracic and Vascular Surgery
Houston, Texas, 77030
Columbia University Medical Center
New York, New York, 10032
Vein Healthcare Center
South Portland, Maine, 04106
Stony Brook University Hospital
Stony Brook, New York, 11794
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
Official title: 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.
Read the 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.
- Conditions
- Varicose Veins
- Being tested
- Varithena®, FDA-approved Endothermal Ablation (ETA) systems
- Keywords
- Great Saphenous Vein Incompetence
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varithena®Drug
Varithena® (polidocanol injectable foam) 1%
FDA-approved Endothermal Ablation (ETA) systemsDevice
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.
| Study group | Role | What they receive |
|---|---|---|
| Varithena® | Active comparator | Varithena® (polidocanol injectable foam) 1% Receives: Drug: Varithena® |
| FDA-approved ETA systems | Active comparator | FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems. Receives: Device: FDA-approved Endothermal Ablation (ETA) systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
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.
Measured: Baseline to 3-month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start10 Feb 2023
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Why it stopped: Enrollment challenges and a difficult insurance coverage landscape
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial 1:1 assignment
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312970
- Sponsor's protocol ID
- S2473
- Acronym
- VERITAS
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2022
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Randomized Trial Comparing Varithena to Endothermal Ablation for the Treatment of the Great Saphenous Vein
- ClinicalTrials.gov ID
- NCT05312970
- Acronym / sponsor ID
- VERITAS / S2473
- Conditions
- Varicose Veins
- Keywords
- Great Saphenous Vein Incompetence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges and a difficult insurance coverage landscape
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Posted 20 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial 1:1 assignment
| Arm | Type | Receives |
|---|---|---|
| Varithena® | Active comparator | Drug: Varithena®Varithena® (polidocanol injectable foam) 1% |
| FDA-approved ETA systems | Active comparator | Device: FDA-approved Endothermal Ablation (ETA) systemsFDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Varithena®Varithena® (polidocanol injectable foam) 1% | Drug | Varithena® |
| FDA-approved Endothermal Ablation (ETA) systemsFDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems. | Device | FDA-approved ETA systems |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Varicose Veins
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varithena® and FDA-approved Endothermal Ablation (ETA) systems in people with Varicose Veins, run by Boston Scientific Corporation at 9 sites in United States.
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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Varicose Veins Symptoms Questionnaire (VVSymQ) (time frame: Baseline to 3-month post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.