This trial is active, not recruiting.

Condition varicosis
Treatment clarivein
Sponsor Rijnstate Hospital
Collaborator St. Antonius Hospital
Start date November 2010
End date April 2017
Trial size 100 participants
Trial identifier NCT01459263, NL26327.091.09


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients with insufficiency of the greater saphenous vein (GSV) will be included.
Using the ClariVein device, the GSV will be occluded.

Primary Outcomes

Occlusion rate
time frame: 30 days, 1, 2, and 5 years

Secondary Outcomes

Health status
time frame: 30 days, 1, 2, and 5 years
Disease related quality of life
time frame: 30 days, 1, 2, and 5 years
Pain score during procedure
time frame: peri-procedural
2-weeks post-procedure pain score
time frame: two weeks
recovery time
time frame: two weeks
procedural complications
time frame: during procedure
post-procedural complications
time frame: 1 year

Eligibility Criteria

All participants from 18 years up to 90 years old.

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

Additional Information

Official title Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study
Principal investigator Michel MJ Reijnen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Rijnstate Hospital.