Clinical Trial of Endovenous 940 and 1470 Laser Ablation for Treating Great Saphenous Veins (COLA)

This study is currently recruiting participants.
Verified June 2012 by Erasmus Medical Center
Sponsor:
Information provided by (Responsible Party):
Wendy Malskat, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01637181
First received: June 18, 2012
Last updated: July 6, 2012
Last verified: June 2012
  Purpose

A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.


Condition Intervention
Varicose Veins
Insufficiency of Great Saphenous Vein
Procedure: Endovenous laser ablation (EVLA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Pain score and use of painkillers [ Time Frame: 1 week post treatment ] [ Designated as safety issue: No ]
    A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient.

  • Treatment satisfaction [ Time Frame: 1 week post treatment ] [ Designated as safety issue: No ]
    A NRS of satisfaction is filled in by the patient.

  • Health related quality of life [ Time Frame: 0 and 12 weeks post treatment ] [ Designated as safety issue: No ]
    Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient.


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: The adverse events will be assessed at 1 and 12 weeks post treatment. ] [ Designated as safety issue: Yes ]
    Minor complications: ecchymoses and hyperpigmentation. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.

  • Occlusion of the treated GSV (effectiveness) [ Time Frame: The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment. ] [ Designated as safety issue: No ]
    Obliteration of varicose vein and/or absence of reflux (>0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.


Estimated Enrollment: 142
Study Start Date: May 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EVLA 940 nm Procedure: Endovenous laser ablation (EVLA)
EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.
Active Comparator: EVLA 1470 nm Procedure: Endovenous laser ablation (EVLA)
EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.

Detailed Description:

* Study type: Interventional. Randomized comparative clinical trial..

  • Outcome measures:

    • Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
    • Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.
  • Outcome measures time frame:

Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.

* Focus of the study: Varicose great saphenous veins (GSV)

  • Intervention information:

    • Intervention name: endovenous laser ablation (EVLA)
    • Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser
    • Arm information: both interventions are active comparators.
  • Locations:

Rotterdam, Zuid-Holland, The Netherlands

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years old
  • Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec, and diameter of vein > 0.5 cm
  • Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
  • No prior treatment of the insufficient GSV
  • Informed consent

Exclusion Criteria:

  • Acute deep or superficial vein thrombosis
  • Agenesis of deep vein system
  • Vascular malformation or syndrome
  • Post-thrombotic syndrome, occlusive type
  • Pregnancy
  • Immobility
  • Allergy to lidocaine
  • Arterial insufficiency
  • Diameter of GSV ≤ 0.5 mm at puncture site
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637181

Contacts
Contact: Wendy Malskat, MD w.malskat@erasmusmc.nl

Locations
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 CA
Contact: H.A.M. Neumann, Prof         
Sponsors and Collaborators
Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Wendy Malskat, MD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01637181     History of Changes
Other Study ID Numbers: NL38160.078.11
Study First Received: June 18, 2012
Last Updated: July 6, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014