The current study has been designed to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the treatment of GSV insufficiency.
ID
Source
Brief title
Condition
- Venous varices
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes is anatomical succes at 12 months.
Secondary outcome
Secondary outcomes are: intraprocedural pain, technical success, operation
time, postoperative pain, anatomical succes at 1, 6, 12, 24 and 60 month(s),
safety, complications, clinical success, quality of life, aesthetic result,
re-interventions and neo-reflux/vascularization.
Background summary
Chronic venous insufficiency (CVI) of the lower limbs is a common disorder with
a prevalence of superficial vein reflux of 21% in the adult population, which
increases linearly with age. CVI is generally caused by insufficiency of the
great saphenous vein (GSV). Minimally invasive endothermal treatment, for
example, endovenous laser ablation (EVLA) or radiofrequency (RFA), has become
the first line of treatment for superficial venous reflux. However, the use of
endothermal ablation techniques is associated with the thermal damage to
superficial nerves, skin burn, prolonged pain, and tumescent anesthesia can
also be painful. Newer treatments, especially non-thermal ablation, have
potential benefits both for patient acceptability and decreased risk of nerve
injury. For example, mechanochemical endovenous ablation (MOCA), which combines
mechanical endothelial damage with the infusion of sclerosant foam injection.
Fleblogrif (Balton, Poland) is a relatively new MOCA device. The expectation is
that compared to EVLA treatment with Flebogrif is less painful and leads to
faster recovery.
Study objective
The current study has been designed to demonstrate that 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
The intervention group will receive treatment with MOCA using Flebogrif. The
control group will receive treatment with EVLA. Patients will be randomized to
either one of the two treatment arms.
Study burden and risks
Patients included in the control group do not directly benefit from
participation in this study. Patients included in the intervention group might
benefit from treatment with Flebogrif. The expected benefit is less pain during
and after treatment resulting in earlier return to daily activity or work.
Additional risk or side effects from Flebogrif are transient migraine and
allergic reaction on Polidocanol (see the structured risk analysis in Chapter
13). The extra burden for all participants of the study consists of five extra
follow-up visits to the outpatient clinic, physical examinations and duplex
ultrasounds of the treated leg, quality of life questionnaires, aesthetic
scores, and daily pain scores during one week.
Wilhelminalaan 12
Alkmaar 1815JD
NL
Wilhelminalaan 12
Alkmaar 1815JD
NL
Listed location countries
Age
Inclusion criteria
1. Age 18-80 years
2. Unilateral symptomatic primary GSV and SFJ incompetence
3. GSV diameter >= 4 or <= 12 mm
4. GSV treatment length >= 15 cm
Exclusion criteria
1. Bilateral endovenous thermal/MOCA treatment of the GSV
2. Simultaneous ipsilateral endovenous thermal-/MOCA treatment of additional
veins
3. C6 varicose veins
4. Previous ipsilateral GSV or AASV treatment
5. Superficial thrombophlebitis or deep venous thrombosis in the last 6 months
6. Occlusion of deep venous system
7. Coagulation disorders or increased risk of thromboembolism
8. Direct oral anticoagulants or vitamin K antagonists
9. Pregnancy or lactation
10. Immobilization
11. Cognitive impairment or language barrier
12. Allergy or contraindication to Polidocanol
13. Severe renal or liver insufficiency
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74491.029.20 |
| OMON | NL-OMON25145 |