NCT02504684

Brief Summary

Objective: Compare venous occlusion rates at a one-year follow-up comparing 1920-nm versus 1470-nm laser treatment. Design: Non-randomized prospective study. Methods: Adult patients with varicose veins associated with great saphenous reflux were included. Procedures were performed between February and April of 2013. The 1470-nm laser ablation was performed in continuous mode, power being set between 8 and 10 W, while for the 1920-nm it was set between 5 and 6 W. Checking for vein closure was performed during the thermal ablation procedure, LEED (linear endovenous energy density) being calculated after the procedure. Follow-up data were collected at the 7-day, 30-day, 3-month, 6-month and 1-year visits, and involved clinical and ultrasound evaluation, measurement of occlusion extent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

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

February 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

July 15, 2015

Last Update Submit

July 20, 2015

Conditions

Varicose Veins

Keywords

varicose veinsendovenous laser treatmentendovenous thermal ablationsaphenous vein

Outcome Measures

Primary Outcomes (1)

  • Venous segment occlusion at one-year follow-up

    Extent of venous occlusion measured in centimeters. The length of occluded vein segment is measured and compared with total extension of the vein treated with the endolaser.

    one year

Secondary Outcomes (5)

  • Ecchymosis extension

    7 days

  • Presence of induration

    30 days

  • Presence of Paresthesia

    30 days

  • Skin burns

    7 days

  • Deep vein thrombosis

    7 days

Study Arms (2)

1470-nm

ACTIVE COMPARATOR

Endovenous 1470-nm diode laser

Device: Endovenous 1470-nm diode laser

1920-nm Group

EXPERIMENTAL

Endovenous 1920-nm diode laser

Device: Endovenous 1920-nm diode laser

Interventions

Endovenous 1920-nm diode laserDEVICE

Patients with saphenous veins treated with a new 1920-nm diode endolaser.

Also known as: 1920-nm laser
1920-nm Group
Endovenous 1470-nm diode laserDEVICE

Patients with saphenous veins treated with the standard 1470-nm diode endolaser.

Also known as: 1470-nm laser
1470-nm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with varicose veins associated with reflux of great or small saphenous veins

You may not qualify if:

  • Patients under 18 years old or over 70 years.
  • Acute or previous thrombophlebitis or deep vein thrombosis.
  • Pregnant patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children ABC hospital

Belo Horizonte, Minas Gerais, 30431020, Brazil

Location

Related Publications (5)

  • Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555.

    PMID: 21725957RESULT

  • Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15.

    PMID: 22705163RESULT

  • Pan Y, Zhao J, Mei J, Shao M, Zhang J. Comparison of endovenous laser ablation and high ligation and stripping for varicose vein treatment: a meta-analysis. Phlebology. 2014 Mar;29(2):109-19. doi: 10.1177/0268355512473911. Epub 2013 May 6.

    PMID: 23390218RESULT

  • Vuylsteke ME, Vandekerckhove PJ, De Bo T, Moons P, Mordon S. Use of a new endovenous laser device: results of the 1,500 nm laser. Ann Vasc Surg. 2010 Feb;24(2):205-11. doi: 10.1016/j.avsg.2009.06.024. Epub 2009 Sep 11.

    PMID: 19748212RESULT

  • von Hodenberg E, Zerweck C, Knittel M, Zeller T, Schwarz T. Endovenous laser ablation of varicose veins with the 1470 nm diode laser using a radial fiber - 1-year follow-up. Phlebology. 2015 Mar;30(2):86-90. doi: 10.1177/0268355513512825. Epub 2013 Nov 29.

    PMID: 24291781RESULT

MeSH Terms

Conditions

Varicose Veins

Interventions

Lasers, SemiconductorLasers

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Daniel M Pinto, MD

    Instituto Vascular BH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Daniel Mendes Pinto, MD

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 22, 2015

Study Start

February 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

BR(1)