RCT of Mechanochemical Ablation versus Cyanoacrylate Adhesive
Research type
Research Study
Full title
Randomised controlled trial of mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins
IRAS ID
227777
Contact name
Roshan Bootun
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
Summary of Research
Varicose vein disease is a common condition whose management has changed over the years. Traditionally, varicose vein has been treated with surgery, but over the past decade, newer minimally invasive methods have been introduced. These use thermal (heat) energy to treat the veins. However, because of the risk of causing heat damage to surrounding structures, these techniques require tumescent fluid infiltration into the tissues around the vein to minimise these effects. This part of the procedure can be a source of discomfort. More recently, some newer treatment options have become available which do not make use of heat and do not require tumescent fluid injection. These are being claimed as being less painful.
Two of these methods are mechanochemical ablation and cyanoacrylate glue injection. So far, there has not been any direct comparison of these two techniques and the purpose of this study is to provide a direct comparison in a randomised study.
Summary of Results
1 Clinical Trial identification
1.1 Study name:
Randomised clinical trial of mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins1.2 Protocol number: N/A
1.3 Identifiers:
The trial was registered at the ClinicalTrials.gov (NCT03392753)1.4 ABSTRACT:
Purpose of study: The purpose of this study was to compare two different treatment methods for varicose veins to see which one causes less pain and if there was a difference in their efficacy. These methods were mechanochemical ablation (MOCA) and cyanoacrylate adhesive (“glue”).What was tested: This study was carried out to compare mechanochemical ablation (MOCA) to cyanoacrylate adhesive (CAE). Patients were randomised into group A (MOCA) or group B (CAE).
Patients taking part: 167 patients with mean age 56 years who had varicose veins took part in this study across 2 countries.
Results: This study found that pain score was low and similar between patients in the group A and the B group.
Safety: Four patients in the group B developed minor complications (superficial thrombophlebitis and thrombus extensions).2. Name and contact of sponsor
2. Who sponsored this study
This study was sponsored by Imperial College London (Joint Research Compliance Office Reference number:17HH4084).3. General information about the clinical trial
3.1 Where was the study done?
This trial took place in the following countries:
• United Kingdom
• Singapore3.2 When was this done?
This trial started in November 2017 and ended in January 2020.3.3 What was the main objective of this study?
The main objective of this study was to compare two different treatment methods for varicose veins to see which one causes less pain and if there was a difference in their efficacy. Patients were put into one of two groups, receiving MOCA (group A) or CAE (group B)
by chance (randomised) to reduce differences between the groups.4. Population of subjects
4.1 What patient/ people were included in this study?
Patients with varicose vein were randomised to one of two groups.4.2 The number of subjects included in the trail
167 symptomatic patients with varicose veins were randomised into either group A (83 patients) or
group B (84 patients).4.3 Age group and gender breakdown
53 of the patients were women in group A and 46 in group B, with mean age in group A was 57 years and 55 years in group B.4.4 Inclusion and exclusion criteria
Inclusion Criteria
• Adults over 18 years of age
• Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
Exclusion Criteria
• Current DVT
• Recurrent varicose veins
• Arterial disease (ABPI<0.8)
• Vein diameter < 3mm
• Patient who are unwilling to participate
• Inability or unwillingness to complete questionnaires
• Adverse reaction to sclerosant or cyanoacrylate
• Not been involved in another venous trial for at least 6 months5. Which medicines were studied?
The device used for MOCA (group A) was the ClariVein® mechanochemical ablation (MOCA) device (Merit Medical, Utah, USA), whereas the device used for CAE (group B) was the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).6. What were the side effects?
Side effects (in Group A) included: None
Side effects (in Group B) included: Minor complications (superficial thrombophlebitis and thrombus extensions).7. What were the overall results of the study?
The findings of this study showed that pain score was low and similar between patients in the group A and the B group. Follow-up data demonstrated that there was no significant difference between the groups regarding the pain experienced in the ten days postoperative, clinical, and quality of life scores. The time return to normal activities or work, ecchymosis score and occlusion rates between both groups were also comparable.8. How has this study helped patients and researcher?
Finding from this study will be used to inform the researcher and patients that both methods have comparable outcomes. Previous studies have demonstrated that these methods also have similar outcomes to standard methods. This would indicate that the main determinant of which methods to use would be down to cost-effectiveness and clinician and patient opinion.9. Are there plans for further studies?
Cost-effectiveness studies are warranted.10. Where can I find more information about this study?
To learn more about this study, you can find more detailed information on this website at the ClinicalTrials.gov (NCT03392753).REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1457
Date of REC Opinion
18 Sep 2017
REC opinion
Further Information Favourable Opinion