NCT01972633

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Ludwig Boltzmann Institute for Operative Laparoscopy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Insufficiency

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2013-10-30
• Last updated: 2013-10-30

Locations

1 site across 1 country: Austria