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

October 24, 2013 updated by: Dr. Markus Schreiner, Ludwig Boltzmann Institute for Operative Laparoscopy

Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast

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) .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Oberösterreich
      • Linz, Oberösterreich, Austria, 4020
        • Recruiting
        • 2.Chirurgische Abteilung AKh Linz GesmbH
        • Contact:
        • Principal Investigator:
          • Markus MS Schreiner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: day 0
Pain (visual analogue scale) on the day of treatment
day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 10, month 3, month 12
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)
day 10, month 3, month 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
day 10, month 3, month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig Boltzmann Institute for Operative Laparoscopy

Investigators

  • Principal Investigator: Markus Schreiner, 2.Chirurgische Abteilung AKh Linz GesmbH
  • Study Chair: Andreas Shamiyeh, 2. Chirurgische Abteilung AKh Linz GesmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Boltzmann-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Venous Insufficiency

Clinical Trials on Laser

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe