The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation
SLEDGE
Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial
1 other identifier
interventional
203
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
2 active sites
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 29, 2017
CompletedStudy Start
First participant enrolled
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2021
CompletedMay 20, 2021
May 1, 2021
4.3 years
January 29, 2017
May 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 month
Secondary Outcomes (2)
Pain score
day 1
Pain score
day 7
Other Outcomes (4)
Number of patients with adverse events
3 month
Paresthesia
3 month
Deep venous thrombosis
day 7
- +1 more other outcomes
Study Arms (3)
Endovenous laser ablation (EVLA) 5W
ACTIVE COMPARATOROne 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 COMPARATOROne 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 COMPARATOROne of three different regimens of endovenous laser ablation, the fiber pullback speed 1.5 mm/s, laser power 10 W, LEED 67 J/cm
Interventions
Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber
Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russialead
- Medalp Private Surgery Cliniccollaborator
- Garantcliniccollaborator
Study Sites (2)
Clinic of Phlebology and Laser Surgery
Chelyabinsk, Russia
GarantClinic
Moscow, Russia
Related Publications (1)
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.
PMID: 37172934DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief surgeon
Study Record Dates
First Submitted
January 29, 2017
First Posted
January 31, 2017
Study Start
January 30, 2017
Primary Completion
May 19, 2021
Study Completion
May 19, 2021
Last Updated
May 20, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
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)