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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.

NCT ID: NCT01722019

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2022-08-31

Brief Summary

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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,…

Detailed Description

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Conditions

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Chronic Venous Insufficiency C2 or Higher

Keywords

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venous insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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radiofrequency ablation with VNUS closure fast

Radiofrequency ablation will be performed with VNUS closure fast.

Group Type ACTIVE_COMPARATOR

VNUS closure fast

Intervention Type DEVICE

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

laser ablation and Tulip fiber

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

Group Type EXPERIMENTAL

Tulip fiber

Intervention Type DEVICE

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

Interventions

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Tulip fiber

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

VNUS closure fast

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Venous Forum.

UNKNOWN

Sponsor Role collaborator

Benelux Society of Phlebology.

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carend Randon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

University Hospital Leuven

Leuven, , Belgium

Site Status

Sint-Andriesziekenhuis Tielt

Tielt, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Related Info

Other Identifiers

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2012/693

Identifier Type: -

Identifier Source: org_study_id