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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014