506 Participants Needed

VenaSeal for Venous Reflux Disease

Recruiting at 34 trial locations
SP
SA
AJ
Overseen ByAnalyn Jackson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Endovascular
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

How does the VenaSeal treatment differ from other treatments for venous reflux disease?

The VenaSeal treatment is unique because it uses a special adhesive to close veins without the need for heat or injections of numbing fluid, making it less invasive than traditional methods like surgical stripping or endothermal ablation.12345

Who Is on the Research Team?

Dr. Kathleen Gibson, MD - Bellevue, WA ...

Kathleen Gibson, MD

Principal Investigator

Lake Washington Vascular, US

MG

Manjit Gohel, MD

Principal Investigator

Addenbrooke's Hospital, UK

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My target vein for treatment is 10 cm or longer.
Eligibility for treatment:
Patient has a target vein diameter of ≥3 mm throughout the intended treated segment of the target vein as measured by DUS while patient is standing
See 6 more

Exclusion Criteria

IFU contraindications:
I cannot have surgical stripping or VenaSeal due to specific health reasons.
VLU Study: Patient has VenaSeal™ system IFU contraindication(s)
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with VenaSeal™ Closure System, Surgical Stripping, or Endothermal Ablation (ETA) based on randomization

Index procedure
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Multiple visits (in-person and virtual) at 30 days, 6, and 12 months

Long-term Follow-up

Extended monitoring for anatomic closure and adverse events

60 months
Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Endothermal Ablation (ETA)
  • Surgical Stripping
  • VenaSeal™ Closure System
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: VenaSeal™ Closure System VLU StudyExperimental Treatment1 Intervention
Group II: VenaSeal™ Closure SystemExperimental Treatment1 Intervention
Group III: Endothermal Ablation (ETA)Active Control1 Intervention
Group IV: Surgical StrippingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Endovascular

Lead Sponsor

Trials
70
Recruited
15,000+

Geoff Martha

Medtronic Endovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Simona Zannetti

Medtronic Endovascular

Chief Medical Officer since 2024

MD from University of Perugia Medical School, research fellowship in vascular surgery at Massachusetts General Hospital, Harvard Medical School

Citations

Predictive factors for changes in remnant stump length during and after the treatment of incompetent truncal saphenous veins using cyanoacrylate. [2021]
VenaSeal closure despite allergic reaction to n-butyl cyanoacrylate. [2020]
Initial Outcomes of Cyanoacrylate Closure, VenaSeal System, for the Treatment of the Incompetent Great and Small Saphenous Veins. [2017]
A multicenter randomized controlled trial of cyanoacrylate closure and surgical stripping for incompetent great saphenous veins. [2022]
Guidelines of the First International Consensus Conference on Endovenous Thermal Ablation for Varicose Vein Disease--ETAV Consensus Meeting 2012. [2022]
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