MOCA using Flebogrif is not inferior to EVLA for the treatment of GSV insufficiency.
ID
Source
Brief title
Condition
- Venous varices
Synonym
Health condition
Great spahenous vein incompetence
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Secondary outcome
Technical success Operation time Postprocedural pain Complications Clinical success Time to return to work Disease-specific quality of life Aesthetic result
Background summary
Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein incompetence (GSV). However, the use of thermal ablation requires tumescence anesthesia and is associated with risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation alternative which combines mechanical endothelial damage with the infusion of sclerosant foam injection. Tumescence anesthesia is not required. Preliminary experiences with MOCA using the Clarivein device showed less intraprocedural and postprocedural pain and a faster clinical improvement. Flebogrif is a relatively new MOCA device. To determine the role of MOCA using Flebogrif in the treatment of primary great saphenous vein incompetence, a well-designed randomized controlled clinical trial of sufficient sample size is required.
Study objective
MOCA using Flebogrif is not inferior to EVLA for the treatment of GSV insufficiency.
Study design
Multicenter, open-label, non-inferiority, randomized controlled trial
Intervention
Flebogrif vs EVLA
Sharon Oud
Wilhelminalaan 12
1815 JD
Alkmaar
The Netherlands
072 548 4444
s.oud@amsterdamumc.nl
Sharon Oud
Wilhelminalaan 12
1815 JD
Alkmaar
The Netherlands
072 548 4444
s.oud@amsterdamumc.nl
Age
Inclusion criteria
- Age 18-80 years
- Unilateral symptomatic primary GSV and saphenofemoral junction (SFJ) incompetence
- GSV diameter ≥ 4 or ≤ 12 mm
- Intrafascial GSV length ≥ 15 cm
Exclusion criteria
- Bilateral endovenous thermal-/MOCA treatment of the GSV
- Simultaneous ipsilateral endovenous thermal-/MOCA treatment of additional veins
- C6 varicose veins
- Previous ipsilateral GSV or anterior accessory saphenous vein treatment
- Superficial thrombophlebitis or deep venous thrombosis in the last 6 months
- Occlusion of deep venous system
- Coagulation disorders or increased risk of thromboembolism
- Use of direct oral anticoagulants or vitamin K antagonists
- Pregnancy or lactation
- Immobilization
- Cognitive impairment or language barrier
- Allergy or contraindication to Polidocanol
- Severe renal or liver insufficiency
Design
Recruitment
IPD sharing statement
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9527 |
| CCMO | NL74491.029.20 |
| OMON | NL-OMON54246 |