Status:
COMPLETED
Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?
Lead Sponsor:
be Medical
Collaborating Sponsors:
Biolitec AG
Conditions:
Varicose Veins
Eligibility:
All Genders
18+ years
Brief Summary
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 detai...
Eligibility Criteria
Inclusion
- Patient is at least 18 years old.
- Patient must sign and date the informed consent form prior to treatment.
- Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥ C2).
- Patient has an insufficient Great Saphenous Vein (GSV), with or without laser ablation of anterior accessory saphenous vein (AASV), posterior accessory saphenous vein (PASV), and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence), suitable for endovenous laser ablation (EVLA).
- Maximum diameter of the to be treated veins is ≤ 14mm.
Exclusion
- Current deep vein thrombosis.
- Acute superficial thrombosis.
- Mean diameter of the to be treated veins \> 14mm.
- Tortuous or very superficial veins considered unsuitable for laser treatment.
- Recurrent varicose veins.
- Pregnancy.
- Coagulopathy or bleeding disorders.
- Contraindications to the use of general or regional anesthesia.
Key Trial Info
Start Date :
April 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03810677
Start Date
April 15 2019
End Date
March 8 2021
Last Update
May 3 2021
Active Locations (2)
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1
Imelda Hospital
Bonheiden, Antwerp, Belgium, 2820
2
Jessa Hospital
Hasselt, Limburg, Belgium, 3500