Varicose VeinsNCT03392753
Mechanochemical Ablation Compared to Cyanoacrylate Adhesive
A study testing Mechanochemical ablation and Cyanoacrylate adhesive in people with Varicose Veins, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Mechanochemical ablation and Cyanoacrylate adhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 18 years of age
- Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charing Cross Hospital, Imperial College London
London, W6 8RF
About this study
Official title: Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins
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.
Read the detailed description
This will be a randomised clinical trial comparing MOCA to CAE. Patients will be randomised into group A (MOCA) or group B (CAE). Only the endovenous ablation part of the procedure will be randomised while the decision as to whether patients should receive treatment of their varicose tributaries will be at the discretion of the clinical team.
The device used for MOCA (group A) will be the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).
The device used for CAE (group B) will be the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).
Re-intervention of the treated saphenous veins will not be decided until at least 3 months after their initial procedure.
- Conditions
- Varicose Veins
- Being tested
- Mechanochemical ablation, Cyanoacrylate adhesive
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanochemical ablationProcedure or surgery
Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)
Cyanoacrylate adhesiveProcedure or surgery
Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
| Study group | Role | What they receive |
|---|---|---|
| Mechanochemical ablation (MOCA) | Active comparator | Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Receives: Procedure: Mechanochemical ablation |
| Cyanoacrylate adhesive (CAE) | Active comparator | Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Receives: Procedure: Cyanoacrylate adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score During Ablation
Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
Measured: On day 0 immediately following vein ablation
Secondary outcomes (9)
Pain Score at the End of the Procedure
Pain score at the end of the procedure using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
Measured: On day 0 following vein ablation and any tributary treatment
Generic Quality of Life as Per EQ-5D Questionnaire
Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life)
Measured: Recorded at 12 months
Disease Specific Quality of Life as Per the AVVQ
Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire (0=best quality of life; 100=worse quality of life)
Measured: Recorded at 12 months
Disease Specific Quality of Life as Per the CIVIQ-20
Using the CIVIQ-20 questionnaire (0=best quality of life; 100=worse quality of life)
Measured: 12 months
Clinical Change as Per VCSS
Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)
Measured: 12 months
Pain Score Over the First 10 Days
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.
Measured: For the first 10 days since procedure
Degree of Bruising at 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.
Measured: 2 weeks
Time to Return to Normal Activities
Length of time in days until normal activities are resumed
Measured: 2 weeks
Occlusion Rates
Rate of occlusion as assessed by duplex ultrasound
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start6 Nov 2017
- Primary completion31 Jul 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392753
- Sponsor's protocol ID
- 17/LO/1457
- Status last verified
- Aug 2022
- First submitted
- 28 Nov 2017
- Last updated
- 4 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):395-404. doi: 10.1001/jamasurg.2022.0298.
PubMed 35385061Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial. Trials. 2018 Aug 7;19(1):428. doi: 10.1186/s13063-018-2807-0.
PubMed 30086774
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins
- ClinicalTrials.gov ID
- NCT03392753
- Acronym / sponsor ID
- 17/LO/1457
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Posted 7 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomised clinical trial comparing MOCA to CAE. Patients will be randomised into group A (MOCA) or group B (CAE). Only the endovenous ablation part of the procedure will be randomised while the decision as to whether patients should receive treatment of their varicose tributaries will be at the discretion of the clinical team.
The device used for MOCA (group A) will be the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).
The device used for CAE (group B) will be the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).
Re-intervention of the treated saphenous veins will not be decided until at least 3 months after their initial procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanochemical ablation (MOCA) | Active comparator | Procedure: Mechanochemical ablationMechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). |
| Cyanoacrylate adhesive (CAE) | Active comparator | Procedure: Cyanoacrylate adhesiveCyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over 18 years of age
- Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
Key exclusion criteria (8 listed)
- Current DVT
- Recurrent varicose veins
- Arterial disease (ABPI<0.8)
- Vein diameter < 3mm
- Patient who are unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanochemical ablationTreatment of incompetent saphenous veins using mechanochemical ablation (Clarivein) | Procedure or surgery | Mechanochemical ablation (MOCA) |
| Cyanoacrylate adhesiveTreatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM) | Procedure or surgery | Cyanoacrylate adhesive (CAE) |
Primary outcome
Pain Score During Ablation
Time frame: 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)
9 secondary outcomes
Pain Score at the End of the Procedure
Time frame: On day 0 following vein ablation and any tributary treatment
Generic Quality of Life as Per EQ-5D Questionnaire
Time frame: Recorded at 12 months
Disease Specific Quality of Life as Per the AVVQ
Time frame: Recorded at 12 months
Disease Specific Quality of Life as Per the CIVIQ-20
Time frame: 12 months
Clinical Change as Per VCSS
Time frame: 12 months
Pain Score Over the First 10 Days
Time frame: For the first 10 days since procedure
Degree of Bruising at 2 Weeks
Time frame: 2 weeks
Time to Return to Normal Activities
Time frame: 2 weeks
Occlusion Rates
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35385061Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):395-404. doi: 10.1001/jamasurg.2022.0298.
- Derived from this study: PubMed 30086774Belramman A, Bootun R, Tang TY, Lane TRA, Davies AH. Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial. Trials. 2018 Aug 7;19(1):428. doi: 10.1186/s13063-018-2807-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanochemical ablation and Cyanoacrylate adhesive in people with Varicose Veins, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score During Ablation (time frame: On day 0 immediately following vein ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03392753, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.