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Early Outcome of Mechanochemical Endovenous Ablation (ClariVein-2)

R

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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