Improving laser treatment of Varicose Veins
- Conditions
- Pain of injection of a tumescent anaesthetic solution used during EndoVenous Laser Ablation of Varicose Veins.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-005575-16-GB
- Lead Sponsor
- Hull & East Yorkshire Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
• Patients aged 18 or over • Primary symptomatic superficial venous insufficiency, CEAP grades C2-C6 • Suitable to undergo EVLA of the GSV to address SFJ and/or GSV reflux on duplex assessment o Defined as retrograde flow = 1second in duration on spectral Doppler analysis • Willing and able to participate and able to give valid, informed consent
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
• Unsuitability for EVLA due to either technical or patient-related factors • Unwillingness/ inability to comply with the requirements for follow-up visits • Known allergy or contraindication to receive any constituents of the study anaesthesia • Varicose veins not due to SFJ or truncal GSV reflux • Pregnant/lactating women • Active Deep Venous Thrombosis/post-thrombotic syndrome of treatment leg • Active or recent (within last 6 weeks) thrombophlebitis of the treatment leg • Previous ipsilateral varicose vein treatment • Patients with impalpable foot pulses and Ankle-Brachial Pressure Index (ABPI) less than 0.8
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method