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| Name | Class |
|---|---|
| Singapore General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanochemical ablation (MOCA) | Active Comparator | Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). |
|
| Cyanoacrylate adhesive (CAE) | Active Comparator | Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanochemical ablation | Procedure | Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score During Ablation | Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain) | On day 0 immediately following vein ablation |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | On day 0 following vein ablation and any tributary treatment |
| Generic Quality of Life as Per EQ-5D Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alun H Davies | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital, Imperial College London | London | W6 8RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35385061 | Derived | 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. | |
| 30086774 | Derived |
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167 patients recruited
Recruitment period: November 2017 and February 2020
Recruitment location:
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| ID | Title | Description |
|---|---|---|
| FG000 | Mechanochemical Ablation (MOCA) | Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein) |
| FG001 | Cyanoacrylate Adhesive (CAE) | Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mechanochemical Ablation (MOCA) | Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein) |
| BG001 | Cyanoacrylate Adhesive (CAE) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score During Ablation | Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain) | Posted | Median | Inter-Quartile Range | Units on a scale | On day 0 immediately following vein ablation |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mechanochemical Ablation (MOCA) | Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Phlebitis | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Roshan Bootun | Imperial College London | +442033117335 | r.bootun@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2018 | Sep 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2018 | Sep 23, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C040229 | MK 6 cyanoacrylate |
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An internet-based randomisation service will be used Outcome assessors will be blinded as to treatment offered
| Cyanoacrylate adhesive | Procedure | Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM) |
|
Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life) |
| 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) | 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) | 12 months |
| Clinical Change as Per VCSS | Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse) | 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. | 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. | 2 weeks |
| Time to Return to Normal Activities | Length of time in days until normal activities are resumed | 2 weeks |
| Occlusion Rates | Rate of occlusion as assessed by duplex ultrasound | 12 months |
| Belramman 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. |
Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | Units on a scale | On day 0 following vein ablation and any tributary treatment |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | Recorded at 12 months |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | Recorded at 12 months |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
|
| Secondary | Clinical Change as Per VCSS | Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse) | Posted | Median | Inter-Quartile Range | score on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | Units on a scale | For the first 10 days since procedure |
|
|
|
| Secondary | 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. | Posted | Number | participants | 2 weeks |
|
|
|
| Secondary | Time to Return to Normal Activities | Length of time in days until normal activities are resumed | Posted | Median | Inter-Quartile Range | days | 2 weeks |
|
|
|
| Secondary | Occlusion Rates | Rate of occlusion as assessed by duplex ultrasound | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | Cyanoacrylate Adhesive (CAE) | Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM) | 0 | 84 | 0 | 84 | 2 | 84 |
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