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

Varicose Veins Clinical Trial

— COLA  

Official title:

Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637181
• Other study ID #: NL38160.078.11
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: February 10, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insufficiency of Great Saphenous Vein
• Varicose Veins

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Treatment satisfaction	A NRS of satisfaction is filled in by the patient.	1 week post treatment	No
Primary	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	No
Secondary	Number of participants with adverse events	Minor complications: ecchymoses and hyperpigmentation. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.	The adverse events will be assessed at 1 and 12 weeks post treatment.	Yes
Secondary	Occlusion of the treated GSV (effectiveness)	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.	The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.	No