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

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810677
• Other study ID #: ELVeS-01
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: March 8, 2021

Study information

• Verified date: April 2021
• Source: be Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Varicose Veins

Intervention

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

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden	Antwerp
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
be Medical	Biolitec AG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomic success	defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography	at 1 month follow-up
Primary	Anatomic success	defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography	at 12 months follow-up
Secondary	Procedural characteristics	Details concerning the index-procedure	at index-procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Post-operative adverse events	numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	at 1 week follow-up
Secondary	Post-operative adverse events	numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	at 1 month follow-up
Secondary	Post-operative adverse events	numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.	at 12 months follow-up
Secondary	Re-interventions	including reason for re-intervention and description of treatment	at 1 week follow-up
Secondary	Re-interventions	including reason for re-intervention and description of treatment	at 1 month follow-up
Secondary	Re-interventions	including reason for re-intervention and description of treatment	at 12 months follow-up