Laser Ablation Versus Mechanochemical Ablation Trial

• Status: Active, not recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hull University Teaching Hospitals NHS Trust; University of Hull
• Treatments: Epinephrine; Epinephryl borate; Lidocaine; Pharmaceutical Solutions; Racepinephrine; Sodium Tetradecyl Sulfate

Criteria

Inclusion Criteria:

• Aged 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

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 medications or dressings used in the 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 an Ankle-Brachial Pressure Index of less than 0.8

• Pregnancy or breast feeding

• Active malignancy

• Immobility

• Involvement in other CTIMP trials within the last 6 months