This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.
Study Type
OBSERVATIONAL
Enrollment
150
Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
Imelda Hospital
Bonheiden, Antwerp, Belgium
Jessa Hospital
Hasselt, Limburg, Belgium
Anatomic success
defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
Time frame: at 1 month follow-up
Anatomic success
defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
Time frame: at 12 months follow-up
Procedural characteristics
Details concerning the index-procedure
Time frame: at index-procedure
Pain scoring using the Visual Analog Scale (VAS)
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
Time frame: discharge
Pain scoring using the Visual Analog Scale (VAS)
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
Time frame: at 1 week follow-up
Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)
The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.
Time frame: at 1 month follow-up
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Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)
The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.
Time frame: at 12 months follow-up
Post-operative adverse events
numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Time frame: at 1 week follow-up
Post-operative adverse events
numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Time frame: at 1 month follow-up
Post-operative adverse events
numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Time frame: at 12 months follow-up
Re-interventions
including reason for re-intervention and description of treatment
Time frame: at 1 week follow-up
Re-interventions
including reason for re-intervention and description of treatment
Time frame: at 1 month follow-up
Re-interventions
including reason for re-intervention and description of treatment
Time frame: at 12 months follow-up