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

NCT ID: NCT01637181

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

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.

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

Conditions

Varicose Veins; Insufficiency of Great Saphenous Vein

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EVLA 940 nm

Group Type: ACTIVE_COMPARATOR

Endovenous laser ablation (EVLA)

Intervention Type: 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 nm

Group Type: ACTIVE_COMPARATOR

Endovenous laser ablation (EVLA)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Wendy Malskat

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erasmus Medical Center

Rotterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 26661521 (View on PubMed)

Other Identifiers

NL38160.078.11

Identifier Type: -

Identifier Source: org_study_id