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

Primary Purpose

Venous Insufficiency

Status
Unknown status
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Laser
Radiofrequency
Sponsored by
Ludwig Boltzmann Institute for Operative Laparoscopy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring endovenous treatment, Laser, Vnus Closure Fast, Varicosis, great saphenous vein, small saphenous vein, Venous Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2.Chirurgische Abteilung AKh Linz GesmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1470nm Laser

VNUS Closure Fast

Arm Description

Patient with varicose vein treated with 1470nm Laser (Biolitec)

Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)

Outcomes

Primary Outcome Measures

Pain
Pain (visual analogue scale) on the day of treatment

Secondary Outcome Measures

Obliteration of the treated vein (GSV or SSV)
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
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)

Full Information

First Posted
December 4, 2012
Last Updated
October 24, 2013
Sponsor
Ludwig Boltzmann Institute for Operative Laparoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT01972633
Brief Title
Endoluminale Obliteration Der Stammvene Mit Dem 1470nm Laser Versus VNUS Closure Fast
Official Title
Endovenous Treatment of the Saphenous Vein With Biolitec 1470nm Laser Versus Vnus Closure Fast
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig Boltzmann Institute for Operative Laparoscopy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
endovenous treatment, Laser, Vnus Closure Fast, Varicosis, great saphenous vein, small saphenous vein, Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1470nm Laser
Arm Type
Active Comparator
Arm Description
Patient with varicose vein treated with 1470nm Laser (Biolitec)
Arm Title
VNUS Closure Fast
Arm Type
Active Comparator
Arm Description
Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)
Intervention Type
Procedure
Intervention Name(s)
Laser
Intervention Description
Endovenous Laser (1470nm) ablation of great or small saphenous vein
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency
Intervention Description
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
Primary Outcome Measure Information:
Title
Pain
Description
Pain (visual analogue scale) on the day of treatment
Time Frame
day 0
Secondary Outcome Measure Information:
Title
Obliteration of the treated vein (GSV or SSV)
Description
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.
Time Frame
day 10, month 3, month 12
Title
Patient´s satisfaction after the intervention
Description
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)
Time Frame
day 10, month 3, month 12
Other Pre-specified Outcome Measures:
Title
paresthesia of the lower leg after intervention
Description
patients are asked if there is any paresthesia of the lower leg - "yes" or "no"
Time Frame
day 10, month 3, month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Schreiner
Phone
0043 732 7806 73295
Email
office@chirurgie-schreiner.at
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Shamiyeh
Phone
0043 732 7806 2133
Email
andreas.shamiyeh@akh.linz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Schreiner
Organizational Affiliation
2.Chirurgische Abteilung AKh Linz GesmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Shamiyeh
Organizational Affiliation
2. Chirurgische Abteilung AKh Linz GesmbH
Official's Role
Study Chair
Facility Information:
Facility Name
2.Chirurgische Abteilung AKh Linz GesmbH
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Bröderbauer
Phone
0043 732 7806 2133
Email
chirurgie2@akh.linz.at
First Name & Middle Initial & Last Name & Degree
Markus MS Schreiner

12. IPD Sharing Statement

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

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