NCT03810677

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

January 11, 2019

Last Update Submit

April 30, 2021

Conditions

Varicose Veins

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (11)

  • Procedural characteristics

    at index-procedure

  • Pain scoring using the Visual Analog Scale (VAS)

    discharge

  • Pain scoring using the Visual Analog Scale (VAS)

    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)

    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)

    at 12 months follow-up

  • +6 more secondary outcomes

Study Arms (1)

Patients with varicose veins, eligible for EVLA

Device: ELVeS® Radial® 2ring slim fiber

Interventions

ELVeS® Radial® 2ring slim fiberDEVICE

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

Patients with varicose veins, eligible for EVLA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (1)

  • Verbist J, Laeremans V, Gryffroy F, Van den Eynde W, Heerinckx C, Haesen D. Durability and efficacy of the ELVeS(R) Radial(R) 2ring slim fiber for multiple ablations. Phlebology. 2023 Dec;38(10):641-648. doi: 10.1177/02683555231193883. Epub 2023 Aug 6.

    PMID: 37545129DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 22, 2019

Study Start

April 15, 2019

Primary Completion

March 8, 2021

Study Completion

March 8, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

BE(2)