NCT03392753

Mechanochemical Ablation Compared to Cyanoacrylate Adhesive

Completed NA Results posted Last updated 4 August 2022

What this trial tests

NA trial testing Mechanochemical ablation in Varicose Veins in 167 participants. Completed in 31 December 2021.

Timeline

6 November 2017

Primary endpoint
31 July 2019

31 December 2021

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	167
Start date	6 November 2017
Primary completion	31 July 2019
Estimated completion	31 December 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• Mechanochemical ablation
• Cyanoacrylate adhesive

Conditions studied

• Varicose Veins — all drugs for Varicose Veins →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Varicose Veins. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Score During Ablation Primary · On day 0 immediately following vein ablation

Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	24	24 – 44.7
Cyanoacrylate Adhesive (CAE)	20	9 – 42

Pain Score at the End of the Procedure Secondary · On day 0 following vein ablation and any tributary treatment

Pain score at the end of the procedure using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	8	3 – 22
Cyanoacrylate Adhesive (CAE)	11	4 – 27

Generic Quality of Life as Per EQ-5D Questionnaire Secondary · Recorded at 12 months

Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life)

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	1	0.74 – 1
Cyanoacrylate Adhesive (CAE)	1	0.73 – 1

Disease Specific Quality of Life as Per the AVVQ Secondary · Recorded at 12 months

Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire (0=best quality of life; 100=worse quality of life)

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	4	0 – 11.9
Cyanoacrylate Adhesive (CAE)	5.9	1.4 – 13.4

Disease Specific Quality of Life as Per the CIVIQ-20 Secondary · 12 months

Using the CIVIQ-20 questionnaire (0=best quality of life; 100=worse quality of life)

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	3.5	0 – 20
Cyanoacrylate Adhesive (CAE)	7.1	0.75 – 21.4

Clinical Change as Per VCSS Secondary · 12 months

Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	2	1 – 3
Cyanoacrylate Adhesive (CAE)	2	1 – 3

Pain Score Over the First 10 Days Secondary · For the first 10 days since procedure

Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain). The mean pain score was recorded daily and a mean value was calculated.

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	10.5	3 – 16
Cyanoacrylate Adhesive (CAE)	7	2.5 – 19

Degree of Bruising at 2 Weeks Secondary · 2 weeks

Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment). The outcome measured is the number of participants with a degree of bruising between category 0-1.

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	53
Cyanoacrylate Adhesive (CAE)	59

Time to Return to Normal Activities Secondary · 2 weeks

Length of time in days until normal activities are resumed

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	7	4 – 10
Cyanoacrylate Adhesive (CAE)	8.5	4 – 10

Occlusion Rates Secondary · 12 months

Rate of occlusion as assessed by duplex ultrasound

Group	Value	95% CI
Mechanochemical Ablation (MOCA)	29
Cyanoacrylate Adhesive (CAE)	31

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mechanochemical Ablation (MOCA)

Serious: 0/83 (0%)

Deaths: 0/83

Cyanoacrylate Adhesive (CAE)

Serious: 0/84 (0%)

Deaths: 0/84

Other adverse events (1 terms — click to expand)

Reaction	System	Mechanochemical Ablation (…	Cyanoacrylate Adhesive (CAE)
Phlebitis	Vascular disorders	—	—

Data from ClinicalTrials.gov NCT03392753 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for great saphenous vein incompetence.
   Whing J, Nandhra S, Nesbitt C, Stansby G. · · 2021 · cited 28× · PMID 34378180 · DOI 10.1002/14651858.cd005624.pub4
2. Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial.
   Belramman A, Bootun R, Tang TY, Lane TRA, et al · · 2022 · cited 8× · PMID 35385061 · DOI 10.1001/jamasurg.2022.0298
3. Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial.
   Belramman A, Bootun R, Tang TY, Lane TRA, et al · · 2018 · cited 3× · PMID 30086774 · DOI 10.1186/s13063-018-2807-0
4. Nonthermal Endovenous Procedures for Varicose Veins: A Health Technology Assessment.
   Ontario Health (Quality) . · · 2021 · cited 2× · PMID 34211617