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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Device: ELVeS® Radial® 2ring slim fiber

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Bonheiden, Antwerp, Belgium, 2820
      • Imelda Hospital
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

150 patients with varicose veins, eligible for treatment with EndoVenous Laser Ablation (EVLA).

Description

Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patient must sign and date the informed consent form prior to treatment.
3. Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥ C2).
4. 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).
5. Maximum diameter of the to be treated veins is ≤ 14mm.

Exclusion Criteria:

1. Current deep vein thrombosis.
2. Acute superficial thrombosis.
3. Mean diameter of the to be treated veins > 14mm.
4. Tortuous or very superficial veins considered unsuitable for laser treatment.
5. Recurrent varicose veins.
6. Pregnancy.
7. Coagulopathy or bleeding disorders.
8. Contraindications to the use of general or regional anesthesia.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with varicose veins, eligible for EVLA	Device: ELVeS® Radial® 2ring slim fiber; Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomic success	defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography	at 1 month follow-up
Anatomic success	defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography	at 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural characteristics	Details concerning the index-procedure	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.	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.	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.	at 1 month 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.	at 12 months follow-up
Post-operative adverse events	numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	at 1 week follow-up
Post-operative adverse events	numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	at 1 month follow-up
Post-operative adverse events	numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	at 12 months follow-up
Re-interventions	including reason for re-intervention and description of treatment	at 1 week follow-up
Re-interventions	including reason for re-intervention and description of treatment	at 1 month follow-up
Re-interventions	including reason for re-intervention and description of treatment	at 12 months follow-up

Collaborators and Investigators

• Sponsor: be Medical
• Collaborators: Biolitec AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): March 8, 2021
• Study Completion (ACTUAL): March 8, 2021

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (ACTUAL): January 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: ELVeS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No