NCT01637181

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

June 18, 2012

Last Update Submit

February 10, 2015

Conditions

Varicose VeinsInsufficiency of Great Saphenous Vein

Outcome Measures

Primary Outcomes (3)

  • Pain score and use of painkillers

    A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient.

    1 week post treatment

  • Treatment satisfaction

    A NRS of satisfaction is filled in by the patient.

    1 week post treatment

  • Health related quality of life

    Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient.

    0 and 12 weeks post treatment

Secondary Outcomes (2)

  • Number of participants with adverse events

    The adverse events will be assessed at 1 and 12 weeks post treatment.

  • Occlusion of the treated GSV (effectiveness)

    The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.

Study Arms (2)

EVLA 940 nm

ACTIVE COMPARATOR
Procedure: Endovenous laser ablation (EVLA)

EVLA 1470 nm

ACTIVE COMPARATOR
Procedure: Endovenous laser ablation (EVLA)

Interventions

Endovenous laser ablation (EVLA)PROCEDURE

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.

EVLA 1470 nmEVLA 940 nm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015 CA, Netherlands

Location

Related Publications (1)

  • Malskat WS, Giang J, De Maeseneer MG, Nijsten TE, van den Bos RR. Randomized clinical trial of 940- versus 1470-nm endovenous laser ablation for great saphenous vein incompetence. Br J Surg. 2016 Feb;103(3):192-8. doi: 10.1002/bjs.10035. Epub 2015 Dec 14.

    PMID: 26661521DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 18, 2012

First Posted

July 11, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

NL(1)