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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. (VNUS vs TULIP)

Primary Purpose

Chronic Venous Insufficiency C2 or Higher

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Tulip fiber
VNUS closure fast
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency C2 or Higher focused on measuring venous insufficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University Hospital
  • University Hospital Leuven
  • Sint-Andriesziekenhuis Tielt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

radiofrequency ablation with VNUS closure fast

laser ablation and Tulip fiber

Arm Description

Radiofrequency ablation will be performed with VNUS closure fast.

Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber.

Outcomes

Primary Outcome Measures

Closure of the greater saphenous vein at 12 months.
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 Outcome Measures

Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Pain.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Pain satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Patient satisfaction rate.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Incapacity to work.
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.

Full Information

First Posted
October 29, 2012
Last Updated
December 28, 2022
Sponsor
University Hospital, Ghent
Collaborators
European Venous Forum., Benelux Society of Phlebology.
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1. Study Identification

Unique Protocol Identification Number
NCT01722019
Brief Title
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.
Acronym
VNUS vs TULIP
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
European Venous Forum., Benelux Society of Phlebology.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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,…

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency C2 or Higher
Keywords
venous insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
radiofrequency ablation with VNUS closure fast
Arm Type
Active Comparator
Arm Description
Radiofrequency ablation will be performed with VNUS closure fast.
Arm Title
laser ablation and Tulip fiber
Arm Type
Experimental
Arm Description
Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber.
Intervention Type
Device
Intervention Name(s)
Tulip fiber
Intervention Description
Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.
Intervention Type
Device
Intervention Name(s)
VNUS closure fast
Intervention Description
Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.
Primary Outcome Measure Information:
Title
Closure of the greater saphenous vein at 12 months.
Description
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.
Time Frame
12 months after procedure
Secondary Outcome Measure Information:
Title
Pain.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
after 5 days
Title
Pain.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
after 14 days
Title
Pain.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
after 1 month
Title
Pain.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
after 6 months
Title
Pain.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
after 1 year.
Title
Patient satisfaction rate.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
after 5 days
Title
Patient satisfaction rate.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 14 days.
Title
Patient satisfaction rate.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 1 month
Title
Pain satisfaction rate.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 6 months
Title
Patient satisfaction rate.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 1 year.
Title
Incapacity to work.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
after 5 days
Title
Incapacity to work.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 14 days
Title
Incapacity to work.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 1 month
Title
Incapacity to work.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 6 months
Title
Incapacity to work.
Description
This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score.
Time Frame
After 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carend Randon, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Sint-Andriesziekenhuis Tielt
City
Tielt
ZIP/Postal Code
8700
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

Learn more about this trial

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.

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