Clinical trial NCT01459263: Early Outcome of Mechanochemical Endovenous Ablation
Official title: Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicosis
Keywords: GSV
insufficiency
ClariVein device
safety
efficacy
QOL
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: St. Antonius Hospital
First posted: 2011-10-25
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with insufficiency of the greater saphenous vein will be included.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occlusion rate
timeFrame: 30 days, 1, 2, and 5 years
Secondary outcomes:
measure: Health status
timeFrame: 30 days, 1, 2, and 5 years
measure: Disease related quality of life
timeFrame: 30 days, 1, 2, and 5 years
measure: Pain score during procedure
timeFrame: peri-procedural
measure: 2-weeks post-procedure pain score
timeFrame: two weeks
measure: recovery time
timeFrame: two weeks
measure: procedural complications
timeFrame: during procedure
measure: post-procedural complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
Study officials:
affiliation: Rijnstate Hospital
name: Michel MJ Reijnen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital
name: Jean-Paul Vries, de, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.