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Glue vs. heat vs. knife: which vein fix wins?

NCT ID NCT03820947

Disease control Sponsor: Medtronic Endovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study tested a medical glue called VenaSeal against heat therapy or surgery for treating venous reflux, a condition where leg veins don't pump blood properly. About 500 adults with early to advanced vein disease took part. The goal was to see which method patients liked more and how well it closed the bad veins.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VenaSeal™ System (medical adhesive)
What this could lead to
If successful, VenaSeal could offer a less painful, needle-free alternative to heat or surgery for closing faulty veins, improving recovery and satisfaction.
What could go wrong
The trial was terminated early, so results may be incomplete. Long-term effectiveness compared to standard treatments is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

506 people

The number who actually took part.

Started

Feb 2020

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is ≥18 years of age 2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for treatment, as confirmed by Duplex Ultrasound (DUS) 3. Eligibility for treatment: * VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSeal™ system and ETA * VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the VenaSeal™ system and surgical stripping * VLU Study: patients should be eligible for treatment with the VenaSeal™ system 4. Treatable refluxing segment of target vein(s) 10 cm in length or longer 5. 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 6. Patient is willing and capable of complying with specified follow-up evaluations at the specified times 7. Patient has an ability to understand the requirements of the study and to provide informed consent Exclusion Criteria: 1. Patient has a known history of allergic sensitivities (including but not limited to cyanoacrylate adhesives), or any other condition, which in the opinion of the investigator may make the patient more susceptible to cyanoacrylate adhesive hypersensitivity 2. Patient has known deep vein obstruction in the target limb, as identified by the site's standard of care 3. Patient has abnormal pulse exam or Ankle-Brachial Index (ABI) \<0.8 4. Patient has acute superficial thrombophlebitis 5. Patient requires any non-target vein treatments in the contralateral or ipsilateral limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months post-procedure 6. Patient has any co-morbid conditions, which in the investigator's opinion may interfere with the patient's compliance with study visits and procedures, or may confound interpretation of study data (e.g., congestive heart failure Class III and IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy \< 1 year) 7. Instructions for Use (IFU) contraindications: * VenaSeal vs. ETA Study: Patient has VenaSeal™ system and/or ETA product's IFU contraindication(s) * VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or VenaSeal™ system IFU contraindication(s) * VLU Study: Patient has VenaSeal™ system IFU contraindication(s) 8. Patient is non-ambulatory 9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at the time of the index procedure 10. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures 11. Patient is currently participating in an investigational drug or device study when the data collected could be conflicting or biased due to participation in another study 12. Patient has documented COVID-19 infection currently or within the past 3 months. Patient is not completely recovered from past COVID-19 infection, per physician's discretion. 13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as confirmed by the independent core laboratory 14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a single photograph (any ulcer curvature around the leg that goes out of sight)

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Conditions

The condition(s) this trial relates to.

varicose disease Varicose Ulcer venous insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous reflux

Contacts and locations

Locations

  • Azienda Ospedaliera di Padova Ospendale Sant' Antonio

    Padova, 35127, Italy

  • Bedfordshire Hospitals NHS Foundation Trust

    Bedford, MK42 9DJ, United Kingdom

  • CHU Dijon Bourgogne

    Dijon, DIjon Cedex, 21079, France

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Clinique Pasteur

    Toulouse, France

  • Clinique du Parc

    Lyon, 69006, France

  • Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)

    Granada, 18016, Spain

  • East Toronto Vascular Clinic

    Toronto, Ontario, M4L 3Y3, Canada

  • Gangnam Severance Hospital

    Seoul, South Korea

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007-2113, United States

  • Imperial College Healthcare NHS Trust - Charing Cross Hospital

    London, W12 0HS, United Kingdom

  • Konkuk University Medical Center

    Seoul, 143-729, South Korea

  • Lake Washington Vascular

    Bellevue, Washington, 98004-4623, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10024, United States

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Orion Medical

    Houston, Texas, 77034, United States

  • Ospedale Fatebenefratelli e Oftalmico

    Milan, 20121, Italy

  • PIMA Heart and Vascular

    Tucson, Arizona, 85718, United States

  • Praxis fur Innere Medizin und Gefäβkrankheiten

    Halle, 06108, Germany

  • Rijnstate - Locatie Arnhem

    Arnhem, 6815, Netherlands

  • Sanitas Hospital Universitario La Zarzuela

    Madrid, 28023, Spain

  • Seoul National University Hospital

    Seoul, 110-744, South Korea

  • Seoul Saint Mary's Hospital

    Seoul, 137-701, South Korea

  • Sunshine Coast University Hospital

    Birtinya, 4575, Australia

  • Valley Vascular Surgical Associates

    Fresno, California, 93701, United States

  • Vascular Care Connecticut

    Darien, Connecticut, 06820, United States

  • Vascular Care Group

    Wellesley, Massachusetts, 02482, United States

  • West London Vascular and Interventional Centre

    Harrow, HA1 3UJ, United Kingdom

  • Wollongong Hospital

    Wollongong, Australia

  • Yale School of Medicine

    New Haven, Connecticut, 06510, United States

  • Yavapai Regional Medical Center

    Prescott Valley, Arizona, 86314-2255, United States

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