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Clinical trial

Comparison of Zero- and Two-centimeter Distance From Sapheno-femoral Junction in Laser Ablation of Long Saphenous Vein Incompetence: Evaluating the Kissing Technique

ID
Name
R.22.09.1805 - 2022/09/06
Description
EVLA is used in in treating refluxing veins, commonly the GSV. The tip of catheter is usually placed 2-2.5 cm distal to the sapheno-femoral junction. This technique theoretically provides the lowest risk for endothermal heat-induced thrombosis (EHIT). In the present study we aimed to evaluate the zero-distance technique (the kissing technique) compared to 2-cm distance from SFJ valve in ablating incompetent GSV.
Trial arms
Trial start
2023-01-04
Estimated PCD
2024-02-04
Trial end
2024-05-04
Status
Active (not recruiting)
Treatment
Saphenous Ablation
Endogenous Laser Ablation (EVLA) uses a laser fibre, which is inserted into the refluxing vein via skin puncture.
Arms:
Two Centimeters from Saphenofemoral Junction, Zero point Ablation
Endogenous Laser Ablation (EVLA)
Endogenous Laser Ablation (EVLA)
Arms:
Two Centimeters from Saphenofemoral Junction, Zero point Ablation
mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline
mixture of 20 mL 2% lidocaine, 1: 200,000 adrenaline and 20 mL 0.5% levobupivacaine in 1 L of 0.9% saline
Arms:
Two Centimeters from Saphenofemoral Junction
Size
800
Primary endpoint
Recurrence
6 months
Eligibility criteria
Inclusion Criteria: * Primary symptomatic VVS (CEAP, C3-C6), sapheno-femoral junction (SFJ) incompetence, and GSV reflux from the groin to below the knee Exclusion Criteria: * history of venous surgery, suspected or proven deep venous thrombosis, history of DVT, reflux of deep veins to distal limb, duplication of GSV, and patients' refusal to participate in the trial.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Laser Ablation of varicose veins', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 800, 'type': 'ESTIMATED'}}
Updated at
2023-01-31

1 organization

1 product

4 indications

Organization
Mansoura University
Product
Mixture of 2% Lidocaine with Adrenaline and 0.5% Levobupivacaine in 0.9% Saline
Indication
Varicose Veins
Indication
Chronic Venous Insufficiency
Indication
Venous Insufficiency
Indication
Venous Leg Ulcer