Early Outcome of Mechanochemical Endovenous Ablation

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

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2018-02-28

Brief Summary

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More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.

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Detailed Description

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Conditions

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Varicosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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GSV insufficiency

Patients with insufficiency of the greater saphenous vein (GSV) will be included.

ClariVein

Intervention Type DEVICE

Using the ClariVein device, the GSV will be occluded.

Interventions

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ClariVein

Using the ClariVein device, the GSV will be occluded.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Insufficiency of the GSV
* Ultrasound criteria for endovenous treatment have been met:
* Diameter GSV between 3-12 mm
* No thrombus present at the GSV part to be treated
* Signed informed consent
* Patient willing to present at follow-up visits
* Age \> 18 jaar

Exclusion Criteria

* Patient is unable to give informed consent
* Patient unable to present at all follow-up visits
* Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation
* Pregnancy and breast feeding
* Known allergy/ contra indication for sclerotherapy
* Previous ipsilateral surgical treatment of varicose veins
* Deep venous vein thrombosis in medical history
* Anticoagulant therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No