Early Outcome of Mechanochemical Endovenous Ablation

Varicosis Clinical Trial

— ClariVein-2  

Official title:

Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459263
• Other study ID #: NL26327.091.09
• Status: Completed
• First received: August 8, 2011
• Last updated: April 25, 2018
• Start date: November 2010
• Est. completion date: February 2018

Study information

• Verified date: April 2018
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicosis

Intervention

Device:
• ClariVein
Using the ClariVein device, the GSV will be occluded.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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(®) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 20 — View 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. — View 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: 10.1583/1 — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion rate	The percentage of GSV occluded	30 days, 1, 2, and 5 years
Secondary	Health status	Using the RAND 36-Item Short Form Health Survey (SF-36)the general health status will be evaluated at the mentioned time points.; The SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.	30 days, 1, 2, and 5 years
Secondary	Disease related quality of life	Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.	30 days, 1, 2, and 5 years
Secondary	Pain score during procedure	The pain will be scored during procedure using the VAS score.	peri-procedural
Secondary	2-weeks post-procedure pain score	The pain will be scored daily for two weeks after the procedure using the VAS score.	two weeks
Secondary	recovery time	The time (in days) after the procedure until patients were able to restart daily activity/daily work	two weeks
Secondary	procedural complications	all complications related to the procedure will be evaluated at the mentioned time points.	during procedure
Secondary	post-procedural complications	all complications related to the procedure will be evaluated at the mentioned time points.	1 year