A Phase 1/2 interventional study of Laser and Radiofrequency in Venous Insufficiency, sponsored by Ludwig Boltzmann Institute for Operative Laparoscopy. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-30.
Sponsored by Ludwig Boltzmann Institute for Operative Laparoscopy · Phase 1/2, Interventional, and Treatment
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) .
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.
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →This is the only study on the registry with Ludwig Boltzmann Institute for Operative Laparoscopy as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient with varicose vein treated with 1470nm Laser (Biolitec)
Procedure: Laser · Procedure: Radiofrequency
Patient with varicose vein treated with VNUS Closure Fast (Radiofrequency System)
Procedure: Laser · Procedure: Radiofrequency
Endovenous Laser (1470nm) ablation of great or small saphenous vein
Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
Pain
Pain (visual analogue scale) on the day of treatment
Time frame: day 0
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.
Time frame: day 10, month 3, month 12
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)
Time frame: day 10, month 3, month 12
paresthesia of the lower leg after intervention
patients are asked if there is any paresthesia of the lower leg - "yes" or "no"
Time frame: day 10, month 3, month 12
This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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