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Varicose VeinsNCT02504684

Treatment of Saphenous Vein Reflux With 1920-nm Diode Laser

A study testing Endovenous 1920-nm diode laser and Endovenous 1470-nm diode laser in people with Varicose Veins, run by Instituto Vascular BH at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Varicose Veins
What is being tested?
Endovenous 1920-nm diode laser and Endovenous 1470-nm diode laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteBrazil
Study dates
Feb 2013to Jan 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Children ABC hospital

    Belo Horizonte, Minas Gerais, 30431020

Other trials in Brazil

About this study

Official title: Endovenous Laser Ablation of the Great Saphenous Vein Comparing 1920-nm and 1470-nm Diode Laser

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.

Read the detailed description

INTRODUCTION The treatment of varicose veins secondary to saphenous vein reflux has undergone a major shift in the past decade, primarily led by the introduction of less invasive techniques. Wavelengths of 810, 940 and 980 nm have higher rates of absorption by hemoglobin. Water chromophore is associated with an initial energy absorption peak at 980 nm, followed by peaks at 1500 and 2000 nm. The energy released into the vein lumen is therefore absorbed by water as well as by cellular and interstitial proteins. In contrast, laser beams with longer wavelengths act more specifically on water absorbance, resulting in less energy expenditure, such as in the case of the 1470-nm diode endolaser. An endoluminal energy density (LEED) around 50-160 J/cm has been demonstrated to effectively lead to venous occlusion, although LEEDs above 100 J/cm can also be associated with higher complication rates. In contrast, the 1920-nm diode laser is more specific for water and hemoglobin chromophores, tissue absorption at this wavelength being at least 2.5 times greater than the one obtained with the 1470-nm laser. It is therefore expected that less energy would be required to generate the same amount of venous closure.

The aim of this study is to compare diode 1920-nm versus 1470-nm laser in the treatment of great saphenous vein reflux. The primary outcome was venous segment occlusion at the one-year follow-up. Secondary outcomes included LEED, postoperative complications, and clinical outcomes measured through the Clinical, Etiology, Anatomical and Pathological classification (CEAP), the Venous Clinical Severity Score (VCSS) and a patient satisfaction scale.

METHODS This is a prospective study to evaluate the results of the 1920-nm vs. 1470-nm laser. Patients agreeing to participate were offered informed consent, recruitment occurring between February and April of 2013. Participants enrolled between February and mid-March of 2013 underwent treatment with the 1470-nm laser, while those enrolled between mid-March and April underwent treatment with the 1920-nm laser.

Patients between 18 and 70 years old who had varicose veins associated with reflux of the great saphenous veins were included. The exclusion criteria were: patients with a previous history of thrombophlebitis, deep vein thrombosis or who had undergone any previous surgery for this condition, thermal ablation or sclerotherapy. For bilateral cases, both limbs were treated during the same surgical session.

Data on clinical history, physical examination, CEAP classification, VCSS (Venous Clinical Severity Score) and VDS (Venous Disability Score) were collected. The extent of the great saphenous reflux was measured along with its main diameter at the level of the saphenofemoral junction as well as at the knee level. Reflux was defined as retrograde when reaching a speed greater than 3 cm/second during a Valsalva maneuver or through leg compression maneuvers.

All patients underwent procedures under spinal anesthesia. The great saphenous vein was punctured at the most distal point of reflux and a 6F introducer was positioned. All cases were conducted with a 600-micron radial fiber positioned between 2.0 and 3.0 cm from the saphenofemoral junction. A tumescence with 0.9% saline solution was placed under ultrasound guidance around the full length of the saphenous vein. All patients were in a 30-degree Trendelenburg position. Surgical procedures involved the saphenous ablation and phlebectomy.

Saphenous ablation with a 1470-nm laser was performed in continuous mode, with a power of 8 to 10 W, determined as a function of the diameter of the vessel as well as surgeon's preference. The 1920-nm laser was also used in continuous mode, with 5 to 6 W power. Vein closure monitoring during the thermal ablation procedure was conducted through ultrasound while pulling-off the fiber. At the end of the procedure, the total amount of energy used in each limb was recorded for LEED calculation, measured as total energy used in the limb (J) over vein length (cm).

First follow-up occurred at postoperative week one, with subsequent evaluation at 30 days, three months, six months and one year. At each assessment, symptoms were recorded and an ultrasound evaluation was performed. Patient satisfaction was evaluated at 1-week through the following questions "Are you satisfied with your surgery?" and "Would you choose the same treatment again?" Both questions were presented as a Likert scale where 0 = very satisfied, 1 = satisfied, 2 = indifferent, 3 = not satisfied, 4 = very dissatisfied.

The primary endpoint for this study was the percentage of occluded venous segments at the 6-month follow-up. Extension of the occluded saphenous vein segment was measured at each visit through a tape guided by ultrasound to determine occlusion points. A segment was considered patent if it was compressible and with reflux after muscle compression in a standing position. The length of the occluded vein segment was compared with the length of the segment where thermal ablation was performed, thus allowing us to calculate the segment closure percentage. Secondary end-points were the presence of ecchymosis, induration, paresthesia, skin burns and deep vein thrombosis.

Conditions
Varicose Veins
Being tested
Endovenous 1920-nm diode laser, Endovenous 1470-nm diode laser
Keywords
varicose veins, endovenous laser treatment, endovenous thermal ablation, saphenous vein
Medical subject headings
Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovenous 1920-nm diode laserDevice

    Also called 1920-nm laser

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

  • Endovenous 1470-nm diode laserDevice

    Also called 1470-nm laser

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

Study groups in NCT02504684
Study groupRoleWhat they receive
1470-nmActive comparatorEndovenous 1470-nm diode laser
Receives: Device: Endovenous 1470-nm diode laser
1920-nm GroupExperimentalEndovenous 1920-nm diode laser
Receives: Device: Endovenous 1920-nm diode laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: one year

Secondary outcomes (5)
  1. Ecchymosis extension

    Extent of ecchymosis noticed after endolaser treatment of the saphenous veins measured in centimeters and compared to the total extension of vein treated with the endolaser.

    Measured: 7 days

  2. Presence of induration

    Induration noticed on the saphenous vein path.

    Measured: 30 days

  3. Presence of Paresthesia

    Presence or absence of paresthesia in the limb treated by endovenous laser

    Measured: 30 days

  4. Skin burns

    Presence or absence of skin burns in the limb treated by a endovenous laser

    Measured: 7 days

  5. Deep vein thrombosis

    Presence or absence of deep vein thrombosis diagnosed by ultrasound in the limb treated by endovenous laser

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2015 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02504684
Sponsor's protocol ID
20130220
Status last verified
Jul 2015
First submitted
15 Jul 2015
Last updated
22 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21725957
  • 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.

    PubMed 22705163
  • 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.

    PubMed 23390218
  • 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.

    PubMed 19748212
  • 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.

    PubMed 24291781

Questions about this trial

What is this clinical trial studying?

A study testing Endovenous 1920-nm diode laser and Endovenous 1470-nm diode laser in people with Varicose Veins, run by Instituto Vascular BH at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Venous segment occlusion at one-year follow-up (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02504684, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.

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