N/A
Completed N=167
Mechanochemical Ablation Compared to Cyanoacrylate Adhesive
Source: ClinicalTrials.gov NCT03392753 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Pain Score During Ablation — 24; 20 Units on a scale
Summary
This study will be comparing the treatment of varicose veins using either mechanochemical ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving either MOCA or CAE.
The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score During Ablation |
24; 20 | — |
| SECONDARY Pain Score at the End of the Procedure |
8; 11 | — |
| SECONDARY Generic Quality of Life as Per EQ-5D Questionnaire |
1; 1 | — |
| SECONDARY Disease Specific Quality of Life as Per the AVVQ |
4; 5.9 | — |
| SECONDARY Disease Specific Quality of Life as Per the CIVIQ-20 |
3.5; 7.1 | — |
| SECONDARY Clinical Change as Per VCSS |
2; 2 | — |
| SECONDARY Pain Score Over the First 10 Days |
10.5; 7 | — |
| SECONDARY Degree of Bruising at 2 Weeks |
53; 59 | — |
| SECONDARY Time to Return to Normal Activities |
7; 8.5 | — |
| SECONDARY Occlusion Rates |
29; 31 | — |
Eligibility 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 months
Data sourced from ClinicalTrials.gov (NCT03392753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.