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| Name | Class |
|---|---|
| St. Antonius Hospital | OTHER |
| OLVG | NETWORK |
| BovenIJ Hospital | OTHER |
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The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA | Active Comparator | Radiofrequency Ablation (RFA) |
|
| MOCA | Experimental | Mechanochemical Endovenous Ablation (MOCA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanochemical Endovenous Ablation (MOCA) | Device | Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion rate | Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success) | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Per-procedural pain score | Pain during the procedure will be compared between treatments using the VAS score | two weeks |
| Complications | Complication at day 30 will be compared between treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery time | Time until daily activities and or work can be resumed (measured in days) | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MMPJ Reijnen, MD | Rijnstate Hospital Arnhem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | Netherlands | |||
| BovenIJ Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23312507 | Background | Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9. | |
| 21679070 |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Radiofrequency ablation (RFA) | Procedure | Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence |
|
|
| 30 days |
| Procedure duration | The duration of the procedures will be compared | 30 days |
| Costs of both treatments | The total costs of both treatments will be compared | 1 year |
| Health status | Using the RAND 36-Item short From Health Survey (SF36) the general health status will be compared between treatments at various time points as specified by the protocol. | 1 year, 5 years |
| Post procedural pain score | Pain during the the first two weeks after the procedure will be compared between treatments using the VAS score | two weeks |
| Disease related quality of life | Using the Aberdeen Varicose Vein Questionnaire (AVVQ)the disease related quality of life will be compared between treatments at various time points as specified by the protocol. | 1 year, 5 years |
| Amsterdam |
| Netherlands |
| OLVG | Amsterdam | Netherlands |
| UMCG | Groningen | Netherlands |
| St. Antonius Hospital | Nieuwegein | Netherlands |
| van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1. |
| 23141679 | Background | van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8. |
| 21854655 | Background | van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch. |
| 31000063 | Derived | Holewijn S, van Eekeren RRJP, Vahl A, de Vries JPPM, Reijnen MMPJ; MARADONA study group. Two-year results of a multicenter randomized controlled trial comparing Mechanochemical endovenous Ablation to RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA trial). J Vasc Surg Venous Lymphat Disord. 2019 May;7(3):364-374. doi: 10.1016/j.jvsv.2018.12.014. |
| 24726004 | Derived | van Eekeren RR, Boersma D, Holewijn S, Vahl A, de Vries JP, Zeebregts CJ, Reijnen MM. Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial. Trials. 2014 Apr 11;15:121. doi: 10.1186/1745-6215-15-121. |