Early Outcome of Mechanochemical Endovenous Ablation

Rijnstate Hospital124 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

124

Conditions

Varicosis

Interventions

ClariVeinDEVICE

Using the ClariVein device, the GSV will be occluded.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

Outcomes

Primary Outcomes

Occlusion rate

The percentage of GSV occluded

Time frame: 30 days, 1, 2, and 5 years

Secondary Outcomes

Health status

Using the RAND 36-Item Short Form Health Survey (SF-36)the general health status will be evaluated at the mentioned time points. The SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.

Time frame: 30 days, 1, 2, and 5 years

Disease related quality of life

Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.

Time frame: 30 days, 1, 2, and 5 years

Pain score during procedure

The pain will be scored during procedure using the VAS score.

Time frame: peri-procedural

2-weeks post-procedure pain score

The pain will be scored daily for two weeks after the procedure using the VAS score.

Time frame: two weeks

recovery time

The time (in days) after the procedure until patients were able to restart daily activity/daily work

Time frame: two weeks

procedural complications

all complications related to the procedure will be evaluated at the mentioned time points.

Time frame: during procedure

post-procedural complications

Data from ClinicalTrials.gov

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