Varicose VeinsNCT03810677
Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?
An observational study of Varicose Veins, run by be Medical at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- ELVeS® Radial® 2ring slim fiber
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Apr 2019to 8 Mar 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients with varicose veins, eligible for treatment with EndoVenous Laser Ablation (EVLA).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Imelda Hospital
Bonheiden, Antwerp, 2820
Jessa Hospital
Hasselt, Limburg, 3500
About this study
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.
- Conditions
- Varicose Veins
- Being tested
- ELVeS® Radial® 2ring slim fiber
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with varicose veins, eligible for EVLA | Not described Receives: Device: ELVeS® Radial® 2ring slim fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic success
defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
Measured: at 1 month follow-up
Anatomic success
defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
Measured: at 12 months follow-up
Secondary outcomes (11)
Procedural characteristics
Details concerning the index-procedure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 12 months follow-up
Post-operative adverse events
numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Measured: at 1 week follow-up
Post-operative adverse events
numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Measured: at 1 month follow-up
Post-operative adverse events
numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Measured: at 12 months follow-up
Re-interventions
including reason for re-intervention and description of treatment
Measured: at 1 week follow-up
Re-interventions
including reason for re-intervention and description of treatment
Measured: at 1 month follow-up
Re-interventions
including reason for re-intervention and description of treatment
Measured: at 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start15 Apr 2019
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biolitec Pharma Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810677
- Sponsor's protocol ID
- ELVeS-01
- Status last verified
- Apr 2021
- First submitted
- 11 Jan 2019
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37545129
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?
- ClinicalTrials.gov ID
- NCT03810677
- Acronym / sponsor ID
- ELVeS-01
- Conditions
- Varicose Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Biolitec Pharma Ltd.
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with varicose veins, eligible for EVLA | – | Device: ELVeS® Radial® 2ring slim fiber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with varicose veins, eligible for treatment with EndoVenous Laser Ablation (EVLA).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELVeS® Radial® 2ring slim fiberDevice for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm | Device | Patients with varicose veins, eligible for EVLA |
Primary outcome
Anatomic success
Time frame: at 1 month follow-up
defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
Anatomic success
Time frame: at 12 months follow-up
defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
11 secondary outcomes
Procedural characteristics
Time frame: at index-procedure
Pain scoring using the Visual Analog Scale (VAS)
Time frame: discharge
Pain scoring using the Visual Analog Scale (VAS)
Time frame: 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)
Time frame: 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)
Time frame: at 12 months follow-up
Post-operative adverse events
Time frame: at 1 week follow-up
Post-operative adverse events
Time frame: at 1 month follow-up
Post-operative adverse events
Time frame: at 12 months follow-up
Re-interventions
Time frame: at 1 week follow-up
Re-interventions
Time frame: at 1 month follow-up
Re-interventions
Time frame: at 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Derived from this study: PubMed 37545129Verbist 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by be Medical at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic success (time frame: at 1 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.