Early Outcome of Mechanochemical Endovenous Ablation (ClariVein-2)

Rijnstate Hospital

Status: Completed

Conditions: Varicosis

Treatments: Device: ClariVein

Study type: Observational

Funder types: Other

Identifiers

NCT01459263

NL26327.091.09

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

124 participants in 1 patient group

GSV insufficiency

Description:

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

Treatment:

Device: ClariVein