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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01972633

Enrollment

140

Registered

2013-10-30

Start date

2010-06-30

Completion date

2014-04-30

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Insufficiency

Keywords

endovenous treatment, Laser, Vnus Closure Fast, Varicosis, great saphenous vein, small saphenous vein, Venous Insufficiency

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.

Interventions

PROCEDURELaser

Endovenous Laser (1470nm) ablation of great or small saphenous vein

PROCEDURERadiofrequency

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Pain	day 0	Pain (visual analogue scale) on the day of treatment

Secondary

Measure	Time frame	Description
Obliteration of the treated vein (GSV or SSV)	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	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

Measure	Time frame	Description
paresthesia of the lower leg after intervention	day 10, month 3, month 12	patients are asked if there is any paresthesia of the lower leg - yes or no

Countries

Austria

Contacts

Primary ContactMarkus Schreiner

office@chirurgie-schreiner.at0043 732 7806 73295

Backup ContactAndreas Shamiyeh

andreas.shamiyeh@akh.linz.at0043 732 7806 2133

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026