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Varithena vs. Endothermal Ablation for Varicose Veins (VERITAS Trial)

Phase 4
Waitlist Available
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Superficial venous disease manifest by clinical symptoms (rVCSS ≥ 4)
CEAP Clinical Condition Classification C2 - C6
Must not have
Post thrombotic deep vein disease above the calf veins
Inability to walk unaided
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3-month post treatment
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares Varithena to Endothermal Ablation to see which works better on varicose veins.

Who is the study for?
This trial is for adults over 18 with varicose veins who've tried compression, diet, exercise, and leg elevation without success. They must have a vein diameter of 5-10mm and be able to attend multiple follow-ups. Excluded are those with recent deep vein thrombosis or clotting disorders, pregnant or breastfeeding women, certain other venous issues, inability to walk or wear compression after treatment, active cancer patients, recent COVID-19 infection, and allergies to specific drugs used in the study.
What is being tested?
The VERITAS trial is comparing Varithena®, a foam treatment for varicose veins against Endothermal Ablation (ETA), which uses heat. The goal is to see which method works better for treating the great saphenous vein responsible for these veins.
What are the potential side effects?
Possible side effects from Varithena® include pain at injection site, blood clots in the vein (phlebitis), nerve damage causing tingling or numbness (neuropathy), and skin discoloration. ETA might cause similar side effects like skin burns due to heat application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have noticeable symptoms of vein disease.
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My vein condition is between mild and severe.
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My vein to be treated is longer than 10cm.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a blood clot in a deep vein above my calf.
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I cannot walk without help.
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I have significant reflux in my leg veins.
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I cannot wear compression bandages or stockings after a procedure.
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I have symptoms of poor blood flow in my legs or an ABPI test result below 0.8.
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I have had treatment for vein issues or clotting in the vein to be treated.
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I am on blood thinners for treatment.
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I have a bulging vein in my leg.
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I currently have cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3-month post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3-month post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Varithena®Active Control1 Intervention
Varithena® (polidocanol injectable foam) 1%
Group II: FDA-approved ETA systemsActive Control1 Intervention
FDA-approved ETA systems, including Radiofrequency ablation (RFA) systems or Endovenous laser ablation (EVLA) systems.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
746 Previous Clinical Trials
857,946 Total Patients Enrolled

Media Library

Endothermal Ablation (ETA) systems Clinical Trial Eligibility Overview. Trial Name: NCT05312970 — Phase 4
Pelvic Varicosities Research Study Groups: Varithena®, FDA-approved ETA systems
Pelvic Varicosities Clinical Trial 2023: Endothermal Ablation (ETA) systems Highlights & Side Effects. Trial Name: NCT05312970 — Phase 4
Endothermal Ablation (ETA) systems 2023 Treatment Timeline for Medical Study. Trial Name: NCT05312970 — Phase 4
~15 spots leftby Jan 2026
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