Skip to main content
OpenTrials
Completed

NCT Number: NCT03810677

Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Imelda Hospital, Bonheiden, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

ELVeS® Radial® 2ring slim fiber

Device

Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

Primary outcomes

  1. Anatomic success

    Time frame: at 1 month follow-up

    defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography

  2. Anatomic success

    Time frame: at 12 months follow-up

    defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography

Secondary outcomes

  1. Procedural characteristics

    Time frame: at index-procedure

    Details concerning the index-procedure

  2. Pain scoring using the Visual Analog Scale (VAS)

    Time frame: discharge

    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.

  3. Pain scoring using the Visual Analog Scale (VAS)

    Time frame: at 1 week follow-up

    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.

  4. Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)

    Time frame: at 1 month follow-up

    The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.

  5. Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)

    Time frame: at 12 months follow-up

    The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.

  6. Post-operative adverse events

    Time frame: at 1 week follow-up

    numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.

  7. Post-operative adverse events

    Time frame: at 1 month follow-up

    numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.

  8. Post-operative adverse events

    Time frame: at 12 months follow-up

    numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.

  9. Re-interventions

    Time frame: at 1 week follow-up

    including reason for re-intervention and description of treatment

  10. Re-interventions

    Time frame: at 1 month follow-up

    including reason for re-intervention and description of treatment

  11. Re-interventions

    Time frame: at 12 months follow-up

    including reason for re-intervention and description of treatment

Sponsors and collaborators

Lead sponsor

be Medical

Industry

Collaborators

  • Biolitec Pharma Ltd.

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.