Clinical Trials Logo
  1. Home
  2. Varicose Veins
  3. NCT02627846

Laser Ablation Versus Mechanochemical Ablation Trial — LAMA  

Varicose Veins Clinical Trial

Official title:
A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency

Clinical Trial Summary

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

Clinical Trial Description

Varicose veins, a very common problem in UK, may cause symptoms including pain, heaviness and itching in the lower legs. Overtime, bleeding and damage to surround soft tissues may develop, leading to venous ulcer which can be very painful, debilitating, difficult to heal and very expensive to treat. Newer minimally invasive techniques are preformed using local anaesthetic. The recovery has been shown to be more rapid, due to less pain and disability when compared to open surgery. These techniques use either heat or a chemical/medicine injected inside the varicose veins to close them permanently. In 2013 National Institute of Health and Care Excellence (NICE) recommended that methods using heat such as endovenous laser ablation (EVLA) should be first choice as the chemical methods have been shown to have a significantly lower treatment success rates in closing varicose veins permanently. Chemical methods however do have their advantages, as they require far fewer injections of local anaesthetic than the heat methods and these injections can be a source of significant discomfort. Since NICE guidelines, a new treatment technique known as mechanochemical ablation (MOCA) using ClariVein® has been developed. This device injects a chemical into the vein through a rotating hollow wire, which causes the vein to narrow and damages the lining of the vein, making the chemical more effective. This new treatment technique aims to match the success rates of the heat method, but with less pain since it avoids most of the local anaesthetic injections. Both treatments are currently used in the UK, however there is insufficient evidence as to whether one is better, or the same. This trial will randomly allocate volunteer patients to have their varicose veins treated with either EVLA or MOCA. The investigators will assess a range of outcomes including pain scores, success rates, complications, quality-of-life and costs to see which, if any, of these treatments offer better results. Long term follow-ups will occur at 5 and 10 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02627846
Study type Interventional
Source Hull University Teaching Hospitals NHS Trust
Contact
Status Completed
Phase Phase 4
Start date June 1, 2015
Completion date September 4, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT02441881 - Trial of Radiofrequency Thermo-ablation Treatments of Great Saphenous Varicose Veins (3-RF Study) N/A
Completed NCT03283800 - Copper Impact on Venous Insufficiency and Lipodermatosclerosis N/A
Recruiting NCT02676908 - Optimum Duration of Compression Stockings After Endovenous Varicose Vein Surgery N/A
Withdrawn NCT01426035 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment Phase 3
Withdrawn NCT01203397 - Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment Phase 3
Recruiting NCT02054325 - Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins Phase 4
Withdrawn NCT03601572 - Hypnoanalgesia in Surgical and Endovenous Treatment of Varicosis
Completed NCT04933591 - Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood N/A
Active, not recruiting NCT02397226 - Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery N/A
Withdrawn NCT02936271 - Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting N/A
Terminated NCT02557542 - Pilot RCT Evaluating a One Stop Vein Clinic N/A
Completed NCT00758420 - Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence Phase 2/Phase 3
Active, not recruiting NCT00841178 - Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT N/A
Not yet recruiting NCT05508581 - Microwaves Ablation of Varicose Veins N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Active, not recruiting NCT04339075 - Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Completed NCT03392753 - Mechanochemical Ablation Compared to Cyanoacrylate Adhesive N/A
Recruiting NCT04146168 - Lake Washington Vascular VenaSeal™ Post-Market Evaluation
Recruiting NCT02304146 - Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study N/A
Completed NCT01200199 - Validity of Electronic Diary for Monitoring Varicose Veins Symptoms