NCT01459263|Completed
Early Outcome of Mechanochemical Endovenous Ablation
ClariVein-2
Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study
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ClariVein-2
Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study
Sponsor study identifier
observational
124
1 country
2
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2018
Actual (reported)Study Completion
February 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
August 8, 2011
Actual (reported)October 25, 2011
Actual (reported)February 2018
Actual (reported)February 2018
Actual (reported)Occlusion rate
The percentage of GSV occluded
30 days, 1, 2, and 5 years
Health status
30 days, 1, 2, and 5 years
Disease related quality of life
30 days, 1, 2, and 5 years
Pain score during procedure
peri-procedural
2-weeks post-procedure pain score
two weeks
recovery time
two weeks
Patients with insufficiency of the greater saphenous vein (GSV) will be included.
Using the ClariVein device, the GSV will be occluded.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with insufficiency of the greater saphenous vein will be included.
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1.
van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch.
Michel MJ Reijnen, MD, PhD
Rijnstate Hospital
Jean-Paul Vries, de, MD, Phd
St. Antonius Hospital
124 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2011
First Posted
October 25, 2011
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8.
Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9.
Primary Completion
February 2018
Actual (reported)Study Completion
February 2018
Actual (reported)Last Updated
April 26, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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