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A multicenter, open-label, non-inferiority, randomized controlled trial comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence

A multicenter, open-label, non-inferiority, randomized controlled trial comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25145
Enrollment
320
Registered
2021-02-09
Start date
2021-09-24
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Great spahenous vein incompetence GSV incompetence

Interventions

Flebogrif vs EVLA

Sponsors

Noordwest Ziekenhuisgroep
Lead Sponsor
Angiocare
Collaborator

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Leeftijd 18-80 jaar - Eenzijdige symptomatische primaire SFJ en VSM insufficiëntie - VSM diameter = 4 of = 12 mm - Intrafasciale VSM lengte = 15 cm

Exclusion criteria

Exclusion criteria: - C6 varices - Dubbelzijdige endoveneuze thermische/MOCA behandeling van de VSM - Simultane ipsilaterale endoveneuze thermische/MOCA behandeling van additionele venen - Eerdere VSM of VSMAA behandeling aan dezelfde zijde - Oppervlakkige tromboflebitis of diep veneuze trombose in de afgelopen 6 maanden - Occlusie diep veneuze systeem - Coagulatie stoornissen of verhoogd risico op trombo-embolie - Directe orale anticoagulantia of vitamine K antagonist gebruik - Zwangerschap of lactatie - Immobiliteit - Allergie of contra-indicatie voor Polidocanol - Ernstige nier- of leverinsufficiëntie - Cognitieve beperking of taalbarrière

Design outcomes

Secondary

MeasureTime frame
? Technical success ? Operation time ? Postprocedural pain ? Complications ? Clinical success ? Time to return to work ? Disease-specific quality of life ? Aesthetic result—

Contacts

Public ContactSharon Oud

Noordwest Ziekenhuisgroep Alkmaar

s.oud@amsterdamumc.nl072 548 4444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 5, 2026