Early Outcome of Mechanochemical Endovenous Ablation

Completed

• Conditions: Varicosis
• Interventions: Device: ClariVein

• Registration Number: NCT01459263
• Lead Sponsor: Rijnstate Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GSV insufficiency	ClariVein	Patients with insufficiency of the greater saphenous vein (GSV) will be included.

Primary Outcome Measures

Name	Time	Method
Occlusion rate	30 days, 1, 2, and 5 years	The percentage of GSV occluded

Secondary Outcome Measures

Name	Time	Method
Disease related quality of life	30 days, 1, 2, and 5 years	Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.
Pain score during procedure	peri-procedural	The pain will be scored during procedure using the VAS score.
procedural complications	during procedure	all complications related to the procedure will be evaluated at the mentioned time points.
Health status	30 days, 1, 2, and 5 years	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.
2-weeks post-procedure pain score	two weeks	The pain will be scored daily for two weeks after the procedure using the VAS score.
post-procedural complications	1 year	all complications related to the procedure will be evaluated at the mentioned time points.
recovery time	two weeks	The time (in days) after the procedure until patients were able to restart daily activity/daily work

Trial Locations

Locations (2)

St. Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands