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| Name | Class |
|---|---|
| Medalp Private Surgery Clinic | OTHER |
| Garantclinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovenous laser ablation (EVLA) | Procedure | Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain (numeric rating scale) | day 1 |
| Pain score | Pain (numeric rating scale) | day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | 3 month | |
| Paresthesia | 3 month | |
| Deep venous thrombosis |
Inclusion Criteria:
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
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Phlebology and Laser Surgery | Chelyabinsk | Russia | ||||
| GarantClinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37172934 | Derived | 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. |
| Label | URL |
|---|---|
| the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). ClinicalTrials.gov ID: NCT03035747 | View source |
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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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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Laser | Device | Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm |
|
| day 7 |
| Superficial venous thrombosis | day 7 |
| Moscow |
| Russia |