Early Outcome of Mechanochemical Endovenous Ablation (ClariVein-2)

This study is ongoing, but not recruiting participants.
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: September 2, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Varicosis
Device: ClariVein

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • Occlusion rate [ Time Frame: 30 days, 1, 2, and 5 years ] [ Designated as safety issue: Yes ]
    The percentage of GSV occluded


Secondary Outcome Measures:
  • Health status [ Time Frame: 30 days, 1, 2, and 5 years ] [ 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: 30 days, 1, 2, and 5 years ] [ 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

  • procedural complications [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
    all complications related to the procedure will be evaluated at the mentioned time points.

  • post-procedural complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    all complications related to the procedure will be evaluated at the mentioned time points.


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
GSV insufficiency
Patients with insufficiency of the greater saphenous vein (GSV) will be included.
Device: ClariVein
Using the ClariVein device, the GSV will be occluded.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with insufficiency of the greater saphenous vein will be included.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459263

Locations
Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
Rijnstate Hospital
St. Antonius Hospital
Investigators
Principal Investigator: Michel MJ Reijnen, MD, PhD Rijnstate Hospital
Principal Investigator: Jean-Paul Vries, de, MD, Phd St. Antonius Hospital
  More Information

Publications:
Responsible Party: Michel Reijnen, MD, PhD, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01459263     History of Changes
Other Study ID Numbers: NL26327.091.09
Study First Received: August 8, 2011
Last Updated: September 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Rijnstate Hospital:
GSV
insufficiency
ClariVein device
safety
efficacy
QOL

ClinicalTrials.gov processed this record on April 17, 2014