Varicose VeinsNCT03856814
Market Penetration of Laser Therapy in Venous Surgery: Ziekenhuis Oost-Limburg - Ziekenhuis Maas En Kempen Center Experience
An observational study of Varicose Veins, run by Duomed at 1 site in Belgium.
Trial summary
The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser… 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 used for EndoVenous Laser Ablation
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2019to 8 Nov 2023
- How long will I take part?
- 6 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: 500 patients with varicose veins, indicative for treatment with Endovenous laser ablation (EVLA) or Surgery (ligation/stripping) according to routine patient care.
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 or recurrent symptomatic varicose veins (CEAP grade ≥ C2).
- Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).
Who cannot join
- Current deep vein thrombosis.
- Acute superficial thrombosis.
- Pregnancy.
- Coagulopathy or bleeding disorders.
- Contraindications to the use of general or regional anesthesia.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Ziekenhuis Oost-Limburg (Sint-Jan,Genk; Sint-Barbara,Lanaken; ZMK,Maaseik)
Genk, Limburg, 3600
About this study
Official title: Market Penetration of Laser Therapy in Venous Surgery: ZOL - ZMK Center Experience
The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).
- Conditions
- Varicose Veins
- Being tested
- ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation
- 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 fiber used for EndoVenous Laser AblationDevice
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 | Patients with varicose veins, indicative for treatment with EndoVenous Laser Ablation (EVLA) using the ELVeS® Radial® 2ring slim fiber or Surgery (ligation/stripping) according to the standard of care of the participating investigators. Receives: Device: ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
The participating investigators will register the incentives (based on clinical examination and/or anatomic outcome by duplex ultrasound, as well as secondary considerations) to use laser ablation or conventional treatment for varicose veins in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.
Measured: At baseline
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
The participating investigators will re-evaluate the chosen treatment option and document this re-evaluation in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.
Measured: At 6 weeks follow-up
Secondary outcomes (18)
Procedural characteristics
Type of anesthesia
Measured: At index-procedure
Procedural characteristics
Number, type and length of veins treated
Measured: At index-procedure
Procedural characteristics
Total energy per patient and fiber (when using the ELVeS® Radial® 2ring slim fiber)
Measured: At index-procedure
Procedural characteristics
Number of procedures showing technical success, defined as the ability to treat the varicose veins as planned
Measured: At index-procedure
Procedural characteristics
Peri-operative adverse events (bleeding, incomplete treatment, technical defects, difficult visualization, …)
Measured: At index-procedure
Procedural characteristics
Duration of 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: At discharge, up to 1 week
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 6 weeks follow-up
Anatomic success of EndoVenous Laser Ablation (EVLA)
Defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography.
Measured: At 6 weeks follow-up
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
Aberdeen Varicose Vein Questionnaire (AVVQ) is a validated tool for assessing the perceived health of patients with varicose veins. The AVVQ comprises 13 quality of life questions, including a set of manikin legs, on which participants are asked to draw their veins.
Measured: At baseline
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
Aberdeen Varicose Vein Questionnaire (AVVQ) is a validated tool for assessing the perceived health of patients with varicose veins. The AVVQ comprises 13 quality of life questions, including a set of manikin legs, on which participants are asked to draw their veins.
Measured: At 6 weeks follow-up
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
Aberdeen Varicose Vein Questionnaire (AVVQ) is a validated tool for assessing the perceived health of patients with varicose veins. The AVVQ comprises 13 quality of life questions, including a set of manikin legs, on which participants are asked to draw their veins.
Measured: At 6 months follow-up
Post-operative adverse events
Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Measured: At discharge, up to 1 week
Post-operative adverse events
Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Measured: At 6 weeks follow-up
Post-operative adverse events
Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Measured: At 6 months follow-up
Re-interventions
Number of participants with re-interventions
Measured: At discharge, up to 1 week
Re-interventions
Number of participants with re-interventions
Measured: At 6 weeks follow-up
Re-interventions
Number of participants with re-interventions
Measured: At 6 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 posted27 Feb 2019
- Study start15 Mar 2019
- Primary completion13 Jan 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856814
- Sponsor's protocol ID
- BM-VL-01 ZOL
- Status last verified
- Sep 2024
- First submitted
- 4 Feb 2019
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Market Penetration of Laser Therapy in Venous Surgery: ZOL - ZMK Center Experience
- ClinicalTrials.gov ID
- NCT03856814
- Acronym / sponsor ID
- BM-VL-01 ZOL
- Conditions
- Varicose Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 27 Feb 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.
The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with varicose veins | – | Device: ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser AblationPatients with varicose veins, indicative for treatment with EndoVenous Laser Ablation (EVLA) using the ELVeS® Radial® 2ring slim fiber or Surgery (ligation/stripping) according to the standard of care of the participating investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients with varicose veins, indicative for treatment with Endovenous laser ablation (EVLA) or Surgery (ligation/stripping) according to routine patient care.
Key inclusion criteria (4 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 or recurrent symptomatic varicose veins (CEAP grade ≥ C2).
- Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).
Key exclusion criteria (5 listed)
- Current deep vein thrombosis.
- Acute superficial thrombosis.
- Pregnancy.
- Coagulopathy or bleeding disorders.
- Contraindications to the use of general or regional anesthesia.
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 fiber used for EndoVenous Laser AblationDevice for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm | Device | Patients with varicose veins |
Primary outcome
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
Time frame: At baseline
The participating investigators will register the incentives (based on clinical examination and/or anatomic outcome by duplex ultrasound, as well as secondary considerations) to use laser ablation or conventional treatment for varicose veins in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
Time frame: At 6 weeks follow-up
The participating investigators will re-evaluate the chosen treatment option and document this re-evaluation in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.
18 secondary outcomes
Procedural characteristics
Time frame: At index-procedure
Procedural characteristics
Time frame: At index-procedure
Procedural characteristics
Time frame: At index-procedure
Procedural characteristics
Time frame: At index-procedure
Procedural characteristics
Time frame: At index-procedure
Procedural characteristics
Time frame: At index-procedure
Pain scoring using the Visual Analog Scale (VAS)
Time frame: At discharge, up to 1 week
Pain scoring using the Visual Analog Scale (VAS)
Time frame: At 6 weeks follow-up
Anatomic success of EndoVenous Laser Ablation (EVLA)
Time frame: At 6 weeks follow-up
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: At baseline
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: At 6 weeks follow-up
Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)
Time frame: At 6 months follow-up
Post-operative adverse events
Time frame: At discharge, up to 1 week
Post-operative adverse events
Time frame: At 6 weeks follow-up
Post-operative adverse events
Time frame: At 6 months follow-up
Re-interventions
Time frame: At discharge, up to 1 week
Re-interventions
Time frame: At 6 weeks follow-up
Re-interventions
Time frame: At 6 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 5 Sep 2024.
Related trials for Varicose Veins
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Not yet recruiting
Mindfulness Intervention on Minimally Invasive Vascular Surgery
Anxiety, Pain
Active, not recruitingObservational study
Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave
Lower Extremity Varicose Veins, Radiofrequency Ablation
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
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.
1 site 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 Duomed at 1 site 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 4 inclusion and 5 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins. (time frame: At baseline). 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?
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 5 Sep 2024.