What side effects are associated with this type of intervention?

Common treatments for venous reflux disease include the VenaSeal™ Closure System, surgical stripping, and endothermal ablation (ETA). The VenaSeal™ Closure System, which uses a medical adhesive to close veins, generally has a favorable safety profile but can cause side effects such as phlebitis, pain at the injection site, and allergic reactions. Surgical stripping and ETA can lead to complications like bruising, pain, infection, nerve injury, and deep vein thrombosis. Overall, while these treatments are effective, they carry risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Venous Reflux Disease, including endovenous thermal ablation techniques like radiofrequency ablation (RFA) and endovenous laser ablation (EVLA). These methods use heat to close off varicose veins. The VenaSeal™ Closure System, which uses a medical adhesive to seal veins, is another FDA-approved treatment. This system offers a non-thermal, non-tumescent option for vein closure, providing an alternative to thermal ablation techniques.

What other types of research exist?

Promising novel alternatives to the VenaSeal™ Closure System for venous reflux disease include: 1) Endovenous laser ablation (EVLA), which uses laser energy to close off varicose veins; 2) Radiofrequency ablation (RFA), which employs radiofrequency energy for vein closure; 3) Mechanochemical ablation (MOCA), combining mechanical and chemical methods to treat veins; and 4) Clarivein®, a specialized catheter for MOCA. These methods are minimally invasive and have shown efficacy in recent studies.

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VenaSeal for Venous Reflux Disease

N/A

Waitlist Available

Led By Manjit Gohel, MD

Research Sponsored by Medtronic Endovascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatable refluxing segment of target vein(s) 10 cm in length or longer

Patient is ≥18 years of age

Must not have

VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s)

Patient has acute superficial thrombophlebitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up index procedure through 60 months (through 12 months for venaseal vs. surgical stripping study)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the VenaSeal™ Closure System, which uses a special glue to close off problematic veins. It targets patients with superficial venous disease and those with active venous leg ulcers. The glue seals the vein, redirecting blood flow to healthier veins. The VenaSeal™ Closure System uses cyanoacrylate glue, which has been studied for its effectiveness in treating venous leg ulcers.

Who is the study for?

Adults over 18 with venous reflux in superficial veins, confirmed by ultrasound. They must have a vein diameter of at least 3mm and be able to follow the study's procedures. Pregnant or breastfeeding women, non-ambulatory individuals, those with certain health conditions like heart failure or severe liver dysfunction, or recent COVID-19 infection are excluded.

What is being tested?

The trial compares the VenaSeal™ Closure System against traditional treatments for varicose veins: surgical stripping and endothermal ablation (ETA). It aims to determine which method is more effective for treating different stages of superficial venous disease.

What are the potential side effects?

Possible side effects include allergic reactions to the VenaSeal adhesive, skin irritation or inflammation at treatment sites, bruising, nerve damage leading to numbness or tingling sensations, and potential complications from heat-based ETA such as burns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My target vein for treatment is 10 cm or longer.

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I am 18 years old or older.

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I understand what participating in the study involves and can give my consent.

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I have confirmed vein issues in my legs that cause symptoms or skin changes.

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I am eligible for treatment with the VenaSeal™ system.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have surgical stripping or VenaSeal due to specific health reasons.

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I have a clot in a vein near the surface of my skin.

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My blood flow in my legs is poor, confirmed by tests.

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I have a confirmed deep vein blockage in my limb.

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I cannot walk on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ index procedure through 60 months (through 12 months for venaseal vs. surgical stripping study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~index procedure through 60 months (through 12 months for venaseal vs. surgical stripping study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and index procedure through 60 months (through 12 months for venaseal vs. surgical stripping study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)

Time to ulcer healing (For VLU study)

Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)

+1 more

Secondary study objectives

Additional adverse events

Adverse events (AEs) occurring in the target limb

Anatomic closure of primary target vein

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: VenaSeal™ Closure System VLU StudyExperimental Treatment1 Intervention

CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSeal™ Closure System

Group II: VenaSeal™ Closure SystemExperimental Treatment1 Intervention

CEAP 2-5 subjects will be randomized to VenaSeal™ Closure System vs. ETA or Surgical Stripping

Group III: Endothermal Ablation (ETA)Active Control1 Intervention

CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or ETA

Group IV: Surgical StrippingActive Control1 Intervention

CEAP 2-5 subjects will be randomized to either VenaSeal™ Closure System or surgical stripping (outside of the United States only)

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The VenaSeal™ Closure System treats Venous Reflux Disease by using a medical adhesive to close the affected veins, preventing blood from flowing backward and pooling. This method is minimally invasive and reduces recovery time compared to traditional surgery. Surgical stripping involves physically removing the problematic veins, while endothermal ablation uses heat to seal them shut. Both methods aim to redirect blood flow to healthier veins, alleviating symptoms like swelling, pain, and varicose veins. These treatments are crucial for improving the quality of life for patients by addressing the underlying cause of venous insufficiency and preventing complications.

Endoscopic therapy for gastroesophageal reflux disease.