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

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01972633
• Other study ID #: Boltzmann-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 4, 2012
• Last updated: October 24, 2013
• Start date: June 2010
• Est. completion date: April 2014

Study information

• Verified date: October 2013
• Source: Ludwig Boltzmann Institute for Operative Laparoscopy
• Contact: Markus Schreiner
• Phone: 0043 732 7806 73295
• Email: office[@]chirurgie-schreiner.at
• Is FDA regulated: No
• Health authority: Austria: ethical review committee
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Procedure:
• Laser
Endovenous Laser (1470nm) ablation of great or small saphenous vein
• Radiofrequency
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein

Locations

Country	Name	City	State
Austria	2.Chirurgische Abteilung AKh Linz GesmbH	Linz	Oberösterreich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute for Operative Laparoscopy

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	paresthesia of the lower leg after intervention	patients are asked if there is any paresthesia of the lower leg - "yes" or "no"	day 10, month 3, month 12	No
Primary	Pain	Pain (visual analogue scale) on the day of treatment	day 0	Yes
Secondary	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.	day 10, month 3, month 12	Yes
Secondary	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)	day 10, month 3, month 12	No