A clinical trial comparing the use of endovenous laser ablation and mechanochemical ablation in the management of varicose veins in the legs.

Conditions: Varicose veins (VVs) or Superficial Venous Insufficiency (SVI) of the legs results from inflammation mediated damage to vein structure, allowing reverse flow. SVI affects 30% of adults and is associated with symptoms causing pain and disability
furthermore 3-10% have soft tissue damage and 1-2% suffer with venous ulcer disease.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2015-000730-30-GB

Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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