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Early Outcome of Mechanochemical Endovenous Ablation (ClariVein-2)

This study is currently recruiting participants.
Verified October 2011 by Rijnstate Hospital
Sponsor:
Collaborator:
St. Antonius Hospital
Information provided by (Responsible Party):
Michel Reijnen, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01459263
First received: August 8, 2011
Last updated: October 24, 2011
Last verified: October 2011
History of Changes

August 8, 2011
October 24, 2011
November 2010
November 2011   (final data collection date for primary outcome measure)
  • Occlusion rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The percentage of GSV occluded
  • Complications during procedure [ Time Frame: peri-procedural ] [ Designated as safety issue: Yes ]
    Complictaions during the procedure will be recorded and followed
  • Post-procudure complications [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    all complications related to the procedure will be evaluated at the mentioned time points.
Same as current
Complete list of historical versions of study NCT01459263 on ClinicalTrials.gov Archive Site
  • Health status [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.

  • Disease related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.
  • Pain score during procedure [ Time Frame: peri-procedural ] [ Designated as safety issue: No ]
    The pain will be scored during procedure using the VAS score.
  • 2-weeks post-procedure pain score [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    The pain will be scored daily for two weeks after the procedure using the VAS score.
  • recovery time [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    The time (in days) after the procedure until patients were able to restart daily activity/daily work
Same as current
Not Provided
Not Provided
 
Early Outcome of Mechanochemical Endovenous Ablation
Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study

More than 25 per cent 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 tumescentless 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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with insufficiency of the greater saphenous vein will be included.
Varicosis
Device: ClariVein
Using the ClariVein device, the GSV will be occluded.
GSV insufficiency
Patients with insufficiency of the greater saphenous vein (GSV) will be included.
Intervention: Device: ClariVein

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
November 2017
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Insufficiency of the GSV
  • Ultrasound cirteria for endovenous treatment have been met:
  • Diameter GSV between 3-12 mm
  • Geen trombus in een deel van het te behandelen VSM traject
  • Signed informed consent
  • Patient willing to present at follow-up visits
  • Age > 18 jaar

Exclusion Criteria:

  • Patient is not able 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 treatmetn of varicose veins
  • Deep venous vein thrombosis in medical history
  • anticoagulant therapy
Both
18 Years to 90 Years
No
Contact: Ramon Eekeren, van rvaneekeren@rijnstate.nl
Contact: Michel Reijnen, MD, PhD mreijnen@rijnstate.nl
Netherlands
 
NCT01459263
NL26327.091.09
No
Michel Reijnen, Rijnstate Hospital
Rijnstate Hospital
St. Antonius Hospital
Principal Investigator: Michel MJ Reijnen, MD, PhD Rijnstate Hospital
Principal Investigator: Jean-Paul Vries, de, MD, Phd St. Antonius Hospital
Rijnstate Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP