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OpenTrials
Completed

NCT Number: NCT01459263

Early Outcome of Mechanochemical Endovenous Ablation

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.

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Key information

Conditions

Varicosis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital, Arnhem, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ClariVein

Device

Using the ClariVein device, the GSV will be occluded.

Primary outcomes

  1. Occlusion rate

    Time frame: 30 days, 1, 2, and 5 years

    The percentage of GSV occluded

Secondary outcomes

  1. Health status

    Time frame: 30 days, 1, 2, and 5 years

    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.

  2. Disease related quality of life

    Time frame: 30 days, 1, 2, and 5 years

    Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.

  3. Pain score during procedure

    Time frame: peri-procedural

    The pain will be scored during procedure using the VAS score.

  4. 2-weeks post-procedure pain score

    Time frame: two weeks

    The pain will be scored daily for two weeks after the procedure using the VAS score.

  5. recovery time

    Time frame: two weeks

    The time (in days) after the procedure until patients were able to restart daily activity/daily work

  6. procedural complications

    Time frame: during procedure

    all complications related to the procedure will be evaluated at the mentioned time points.

  7. post-procedural complications

    Time frame: 1 year

    all complications related to the procedure will be evaluated at the mentioned time points.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • St. Antonius Hospital

Registry information

Official study title

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

Acronym: ClariVein-2

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2011
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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