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Varithena vs. Endothermal Ablation for Varicose Veins (VERITAS Trial)
Phase 4
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3-month post treatment
Awards & highlights
VERITAS 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.Check my eligibility
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.See study design
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.
VERITAS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have noticeable symptoms of vein disease.
Select...
My vein condition is between mild and severe.
Select...
I can attend all follow-up visits after my procedure.
Select...
My condition didn't improve with basic treatments like compression, diet, or exercise.
Select...
I have a vein problem in one leg confirmed by an ultrasound showing backward blood flow.
Select...
My vein to be treated is longer than 10cm.
Select...
I am 18 years old or older.
VERITAS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3-month post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3-month post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Varicose Veins Symptoms Questionnaire (VVSymQ)
VERITAS 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.
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Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
716 Previous Clinical Trials
934,405 Total Patients Enrolled
9 Trials studying Varicose Veins
885 Patients Enrolled for Varicose Veins
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a blood clot in a deep vein above my calf.I cannot walk without help.I have noticeable symptoms of vein disease.You are not expected to live for at least 2 more years.My condition didn't improve with basic treatments like compression, diet, or exercise.You are allergic to polidocanol, xylocaine, or epinephrine.My doctor thinks I might need a vein treatment on the same side as my treatment within 3 months.I have significant reflux in my leg veins.My vein condition is between mild and severe.I can attend all follow-up visits after my procedure.I cannot wear compression bandages or stockings after a procedure.I have had COVID-19 recently or currently have it.My condition didn't improve with basic treatments like compression, diet, or exercise.I have had a blood clot in my leg or lung, or a clotting disorder, in the last 3 months.The size of your vein is between 5mm and 10mm.I have a vein problem in one leg confirmed by an ultrasound showing backward blood flow.My vein to be treated is longer than 10cm.I have symptoms of poor blood flow in my legs or an ABPI test result below 0.8.I have had treatment for vein issues or clotting in the vein to be treated.I have had a vein treatment in my affected limb within the last 3 months.I am on blood thinners for treatment.My doctor thinks I might need a vein treatment on the opposite side within 3 months.I have a bulging vein in my leg.I am 18 years old or older.I currently have cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Varithena®
- Group 2: FDA-approved ETA systems
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are ETA systems compliant with federal regulations?
"Given the Phase 4 status of FDA-approved ETA systems, our team at Power has assigned a score of 3 to this treatment's safety."
Answered by AI
Are there remaining opportunities for individuals to partake in this research?
"According to clinicaltrials.gov, the trial is currently seeking participants and has been actively edited since its launch on February 10th 2023."
Answered by AI
How many individuals are actively enrolled in this research trial?
"Indeed, the relevant clinicaltrials.gov listing confirms that this experiment is currently recruiting. It was initially posted on February 10th 2023 and last updated a few days later on 2/15/2023. The trial's organisers are looking for 100 participants at 3 different sites nationwide."
Answered by AI
Who else is applying?
What site did they apply to?
UT Physicians Cardiothoracic and Vascular Surgery
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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