A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency. - Laser Ablation versus Mechanochemical Ablation (LAMA) trial

Hull and East Yorkshire Hospitals NHS Trust0 个研究点开始时间: 2015年4月14日最近更新: 2015年9月28日

适应症

试验速览

暂无简介。

•- Age 18 or over
•- Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
•- Clinical grades C2-C6 on the CEAP system
•- Superficial axial incompetence with proposed treatment lengths of at least 10cm
•- Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
•- Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•- One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
•- Unwilling or inability to comply with the requirements for follow-up visits
•- Known allergy to any medications used during treatment
•- Known right to left circulatory shunt
•- Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
•- Pelvic vein insufficiency
•- Active or recent thrombophlebitis (within 6 weeks)
•- Impalpable foot pulses with Ankle-Brachial Pressure Index of less than 0.8
•- Pregnancy or breast feeding
•- Active malignancy
•- Immobility
•- Have been included in other CTIMP trials within the last 6 months

发起方

Hull and East Yorkshire Hospitals NHS Trust