Varicose VeinsSLEDGENCT03037827
The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation
A study testing Endovenous laser ablation (EVLA) and Laser in people with Varicose Veins, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 2 sites in Russia.
Trial summary
A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. 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?
- Endovenous laser ablation (EVLA) and Laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 2 sitesRussia
- Study dates
- 30 Jan 2017to 19 May 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec No prior treatment of the insufficient GSV Informed consent
Who cannot join
- Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on the thigh Immobility Allergy to lidocaine Arterial insufficiency
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Clinic of Phlebology and Laser Surgery
Chelyabinsk
GarantClinic
Moscow
About this study
Official title: Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial
A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. From many studies, it is known the optimum value of the LEED. However, the same LEED may be obtained by varying the ratio between the laser power and the fiber pullback speed. Power decrease can allow to reduce the incidence of adverse effects of endovenous laser ablation, but keep high efficiency.
- Conditions
- Varicose Veins
- Being tested
- Endovenous laser ablation (EVLA), Laser
- Keywords
- endovenous laser ablation, radial fiber, linear endovenous energy density, 1470 nm, occlusion rate
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous laser ablation (EVLA)Procedure or surgery
Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber
LaserDevice
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 |
|---|---|---|
| Endovenous laser ablation (EVLA) 5W | Active comparator | One of three different regimens of endovenous laser ablation, the fiber pullback speed 0.7 mm/s, laser power 5 W, LEED 71 J/cm Receives: Procedure: Endovenous laser ablation (EVLA); Device: Laser |
| Endovenous laser ablation (EVLA) 7W | Active comparator | One of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm Receives: Procedure: Endovenous laser ablation (EVLA); Device: Laser |
| Endovenous laser ablation (EVLA) 10W | Active comparator | One of three different regimens of endovenous laser ablation, the fiber pullback speed 1.5 mm/s, laser power 10 W, LEED 67 J/cm Receives: Procedure: Endovenous laser ablation (EVLA); Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with a fully obliterated target vein
An ultrasound investigation of the treated vein to find out is the treated vein is fully obliterated or not, and to find out is there any pathological reflux in the vein.
Measured: 3 month
Secondary outcomes (2)
Pain score
Pain (numeric rating scale)
Measured: day 1
Pain score
Pain (numeric rating scale)
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start30 Jan 2017
- Primary completion19 May 2021
- Study completion19 May 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- Medalp Private Surgery Clinic, Garantclinic
- Responsible party
- Principal investigator, Denis Borsuk, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037827
- Sponsor's protocol ID
- A001
- Acronym
- SLEDGE
- Status last verified
- May 2021
- First submitted
- 29 Jan 2017
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collection will take place at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). Access to the data will be available after completion of the study. To access the data will need to send a request to RRT CVD administrator. Register in Russian. Registry now listed in the database ClinicalTrials.gov, ID NCT03035747 (see references)
Publications
Borsuk DA, Fokin AA, Lobastov KV, Tauraginskii RA, Zhdanov KO, Zolotov AV, Arkhipov IS, Galchenko MI. A randomized clinical trial to assess the impact of laser power with constant linear endovenous energy density on outcomes of endovenous laser ablation (SLEDGE trial). J Vasc Surg Venous Lymphat Disord. 2023 Sep;11(5):946-953. doi: 10.1016/j.jvsv.2023.03.020. Epub 2023 May 11.
PubMed 37172934
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT03037827
- Acronym / sponsor ID
- SLEDGE / A001
- Conditions
- Varicose Veins
- Keywords
- endovenous laser ablation, radial fiber, linear endovenous energy density, 1470 nm, occlusion rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, RussiaUniversity, hospital or other
- Collaborators
- Medalp Private Surgery Clinic, Garantclinic
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 31 Jan 2017 (estimated)
- 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.
A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. From many studies, it is known the optimum value of the LEED. However, the same LEED may be obtained by varying the ratio between the laser power and the fiber pullback speed. Power decrease can allow to reduce the incidence of adverse effects of endovenous laser ablation, but keep high efficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endovenous laser ablation (EVLA) 5W | Active comparator | Procedure: Endovenous laser ablation (EVLA), Device: LaserOne of three different regimens of endovenous laser ablation, the fiber pullback speed 0.7 mm/s, laser power 5 W, LEED 71 J/cm |
| Endovenous laser ablation (EVLA) 7W | Active comparator | Procedure: Endovenous laser ablation (EVLA), Device: LaserOne of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm |
| Endovenous laser ablation (EVLA) 10W | Active comparator | Procedure: Endovenous laser ablation (EVLA), Device: LaserOne of three different regimens of endovenous laser ablation, the fiber pullback speed 1.5 mm/s, laser power 10 W, LEED 67 J/cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec No prior treatment of the insufficient GSV Informed consent
Key exclusion criteria (1 listed)
- Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on the thigh Immobility Allergy to lidocaine Arterial insufficiency
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 |
|---|---|---|
| Endovenous laser ablation (EVLA)Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber | Procedure or surgery | Endovenous laser ablation (EVLA) 10W, Endovenous laser ablation (EVLA) 5W, Endovenous laser ablation (EVLA) 7W |
| LaserDevice for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm | Device | Endovenous laser ablation (EVLA) 10W, Endovenous laser ablation (EVLA) 5W, Endovenous laser ablation (EVLA) 7W |
Primary outcome
The number of participants with a fully obliterated target vein
Time frame: 3 month
An ultrasound investigation of the treated vein to find out is the treated vein is fully obliterated or not, and to find out is there any pathological reflux in the vein.
2 secondary outcomes
Pain score
Time frame: day 1
Pain score
Time frame: day 7
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 20 May 2021.
- Derived from this study: PubMed 37172934Borsuk DA, Fokin AA, Lobastov KV, Tauraginskii RA, Zhdanov KO, Zolotov AV, Arkhipov IS, Galchenko MI. A randomized clinical trial to assess the impact of laser power with constant linear endovenous energy density on outcomes of endovenous laser ablation (SLEDGE trial). J Vasc Surg Venous Lymphat Disord. 2023 Sep;11(5):946-953. doi: 10.1016/j.jvsv.2023.03.020. Epub 2023 May 11.
- the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). ClinicalTrials.gov ID: NCT03035747Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data collection will take place at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). Access to the data will be available after completion of the study. To access the data will need to send a request to RRT CVD administrator. Register in Russian. Registry now listed in the database ClinicalTrials.gov, ID NCT03035747 (see references)
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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?
A study testing Endovenous laser ablation (EVLA) and Laser in people with Varicose Veins, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 2 sites in Russia.
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 1 inclusion and 1 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 20 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 Russia. 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?
The number of participants with a fully obliterated target vein (time frame: 3 month). 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 NCT03037827, 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 20 May 2021.