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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

Tracking Information
First Submitted Date  ICMJE December 4, 2012
First Posted Date  ICMJE October 30, 2013
Last Update Posted Date October 30, 2013
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
Pain [ Time Frame: day 0 ]
Pain (visual analogue scale) on the day of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 24, 2013)
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"
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast
Official Title  ICMJE Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
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) .
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Venous Insufficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1470nm Laser
    Patient with varicose vein treated with 1470nm Laser (Biolitec)
    Interventions:
    • Procedure: Laser
    • Procedure: Radiofrequency
  • Active Comparator: VNUS Closure Fast
    Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)
    Interventions:
    • Procedure: Laser
    • Procedure: Radiofrequency
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 24, 2013)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01972633
Other Study ID Numbers  ICMJE Boltzmann-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Markus Schreiner, Ludwig Boltzmann Institute for Operative Laparoscopy
Study Sponsor  ICMJE Ludwig Boltzmann Institute for Operative Laparoscopy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markus Schreiner 2.Chirurgische Abteilung AKh Linz GesmbH
Study Chair: Andreas Shamiyeh 2. Chirurgische Abteilung AKh Linz GesmbH
PRS Account Ludwig Boltzmann Institute for Operative Laparoscopy
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP