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Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast

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ClinicalTrials.gov Identifier: NCT01972633
Recruitment Status : Unknown
Verified October 2013 by Dr. Markus Schreiner, Ludwig Boltzmann Institute for Operative Laparoscopy.
Recruitment status was:  Recruiting
First Posted : October 30, 2013
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Markus Schreiner, Ludwig Boltzmann Institute for Operative Laparoscopy

Brief Summary:
There is a difference concerning obliteration rate and postoperative pain after treatment of the saphenous vein with 1470nm laser or VNUS Closure Fast (=radiofrequency method) .

Condition or disease Intervention/treatment Phase
Venous Insufficiency Procedure: Laser Procedure: Radiofrequency Phase 1 Phase 2

Detailed Description:

The endovenous treatment of the insufficient saphenous vein (large saphenous vein and small saphenous vein) is a standard procedure for years. There are different methods that cause an obliteration of the vein using heat. The adventage of these methods are low rates of minor and major complications compared to classic open surgery. There are also advantages concerning cosmetic and recurrence of varicous veins. Actually there are two different methods for the endovenous obliteration of the saphenous vein - lasers with wavelength of 1470nm or 1320nm and the radiofrequency method. The objective of this study is to compare these two different methods concerning postoperative pain, obliteration rate and the rate of pleased patients in 140 patients. All patients get an venous ultrasound investigation to determine the stadium of venous insufficiency. There are consecutive ultrasound investigations 10 days, 3 months and 12 months after surgical treatment.

In this study there are no additional risk factors for the included study patients except the risk of surgery.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
Study Start Date : June 2010
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : April 2014

Arm Intervention/treatment
Active Comparator: 1470nm Laser
Patient with varicose vein treated with 1470nm Laser (Biolitec)
Procedure: Laser
Endovenous Laser (1470nm) ablation of great or small saphenous vein

Procedure: Radiofrequency
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein

Active Comparator: VNUS Closure Fast
Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)
Procedure: Laser
Endovenous Laser (1470nm) ablation of great or small saphenous vein

Procedure: Radiofrequency
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein




Primary Outcome Measures :
  1. Pain [ Time Frame: day 0 ]
    Pain (visual analogue scale) on the day of treatment


Secondary Outcome Measures :
  1. Obliteration of the treated vein (GSV or SSV) [ Time Frame: day 10, month 3, month 12 ]
    An ultrasound investigation of he treated vein is done to find out if the treated vein is fully obliterated or not. If it is not fully obliterated we want to find out if there is any pathological reflux in the vein.

  2. Patient´s satisfaction after the intervention [ Time Frame: day 10, month 3, month 12 ]
    The patient is asked about his/her satisfaction after intervention. This is measured on a numeric scale from 1 to 5 (like schoolmarks in austria or germany). 1=very good, 2=good, 3=average, 4=not so good, 5=bad)


Other Outcome Measures:
  1. paresthesia of the lower leg after intervention [ Time Frame: day 10, month 3, month 12 ]
    patients are asked if there is any paresthesia of the lower leg - "yes" or "no"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • varicosis of great saphenous vein Hach-classification II-III (CEAP-classification: C3-4EPAS2-3PR and/or varicosis of small saphenous vein der Hach-classification I-III CEAP-classification: C3-4EPAS4PR)
  • maximum diameter of the great saphenous vein of 15mm maximum diameter of the small saphenous vein of 12mm

Exclusion Criteria:

  • surgical treatment of the saphenous vein in the past
  • sclerotherapy of the saphenous vein in the past
  • phlebitis or thrombosis of the saphenous vein
  • surgical treatment of an venous ulcer in the past
  • postthrombotic syndrome
  • erysipelas of the leg in the past
  • chronic treatment with pain-killers or chronic alcoholism
  • pregnancy
  • drug allergy against painkillers that are used in this study
  • spinal anesthesia not possible
  • compression bandage not possible
  • patients with polyneuropathy
  • patients with chronic pain
  • persons that do have a connection or persons that are working for one of the jused companies (Laser or VNUS Closure Fast)
  • participation on an other clinical trial that can interfere with this clinical trial
  • missing written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972633


Contacts
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Contact: Markus Schreiner 0043 732 7806 73295 office@chirurgie-schreiner.at
Contact: Andreas Shamiyeh 0043 732 7806 2133 andreas.shamiyeh@akh.linz.at

Locations
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Austria
2.Chirurgische Abteilung AKh Linz GesmbH Recruiting
Linz, Oberösterreich, Austria, 4020
Contact: Katharina Bröderbauer    0043 732 7806 2133    chirurgie2@akh.linz.at   
Principal Investigator: Markus MS Schreiner         
Sponsors and Collaborators
Ludwig Boltzmann Institute for Operative Laparoscopy
Investigators
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Principal Investigator: Markus Schreiner 2.Chirurgische Abteilung AKh Linz GesmbH
Study Chair: Andreas Shamiyeh 2. Chirurgische Abteilung AKh Linz GesmbH

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Responsible Party: Dr. Markus Schreiner, Oberarzt, Ludwig Boltzmann Institute for Operative Laparoscopy
ClinicalTrials.gov Identifier: NCT01972633     History of Changes
Other Study ID Numbers: Boltzmann-001
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Dr. Markus Schreiner, Ludwig Boltzmann Institute for Operative Laparoscopy:
endovenous treatment
Laser, Vnus Closure Fast
Varicosis
great saphenous vein
small saphenous vein
Venous Insufficiency

Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases