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Completed

NCT Number: NCT01722019

Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.

Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,…

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Key information

Conditions

Chronic Venous Insufficiency C2 or Higher Cardiovascular Diseases Vascular Diseases Venous Insufficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Endovenous ablation of the great saphenous vein (GSV) planned
  • Patient signed informed consent
  • Patient must complete the 1 year follow-up
  • CEAP between 2 and 6
  • BMI=<35
  • Diameter of the GSV in upward position less than 20 mm diameter
  • No problems in deep venous system

Exclusion criteria

  • No informed consent is signed
  • Latex allergy
  • Arterial insufficiency
  • Deep vein thrombosis or deep vein insufficiency
  • Klippel Trenaunay
  • Diameter fo GSV > 20 mm
  • Cross dilation with 2 or more insufficient side branches
  • Previous GSV operation
  • Redo-operation
  • Carcinoma less than 1 year ago
  • BMI > 35
  • Liver-insufficiency with contraindication for local tumescence
  • Intake of warfarins
  • Pregnancy, breastfeeding, < 3 months after pregnancy
  • Bilateral GSV insufficiency that has to be treated
  • Cross insufficiency of the accessory saphenous vein or insufficiency of the subterminal valve of the GSV

Treatment and study plan

Tulip fiber

Device

Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.

VNUS closure fast

Device

Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.

Primary outcomes

  1. Closure of the greater saphenous vein at 12 months.

    Time frame: 12 months after procedure

    Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months.

Secondary outcomes

  1. Pain.

    Time frame: after 5 days

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  2. Pain.

    Time frame: after 14 days

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  3. Pain.

    Time frame: after 1 month

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  4. Pain.

    Time frame: after 6 months

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  5. Pain.

    Time frame: after 1 year.

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  6. Patient satisfaction rate.

    Time frame: after 5 days

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  7. Patient satisfaction rate.

    Time frame: After 14 days.

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  8. Patient satisfaction rate.

    Time frame: After 1 month

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  9. Pain satisfaction rate.

    Time frame: After 6 months

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  10. Patient satisfaction rate.

    Time frame: After 1 year.

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  11. Incapacity to work.

    Time frame: after 5 days

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  12. Incapacity to work.

    Time frame: After 14 days

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  13. Incapacity to work.

    Time frame: After 1 month

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  14. Incapacity to work.

    Time frame: After 6 months

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

  15. Incapacity to work.

    Time frame: After 1 year

    This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Benelux Society of Phlebology.
  • European Venous Forum.

Registry information

Official study title

Prospective Multicentric Randomised Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diod Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.

Acronym: VNUS vs TULIP

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Nov 6, 2012
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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