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Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D

NCT02397226•University Hospital, Linkoeping

View on ClinicalTrials.gov

Summary

200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Insufficient great saphenous vein
•Possible to treat with both radiofrequency ablation and high ligation/stripping
•Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6

Exclusion Criteria

•Previous intervention in the affected leg
•Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
•Small saphenous vein insufficiency with diameter \>6 mm and/or flow \>100ml/min
•Patient that is not able to perform plethysmography

Locations (2)

University Hospital Linköping

Linköping, Östergötland County, Sweden

Vrinnevisjukhuset

Norrköping, Östergötland County, Sweden

Key Dates

Start Date

September 1, 2014

Primary Completion Date

November 25, 2021

Completion Date

December 31, 2026

Last Updated

December 6, 2024

Enrollment

198

ACTUAL participants

Conditions

Varicose VeinsVenous Insufficiency

Interventions

Radiofrequency ablation

PROCEDURE

High ligation/stripping

PROCEDURE

Radiofrequency ablation catheter

DEVICE

Tumescent anesthesia

PROCEDURE

General anesthesia

PROCEDURE

Vein stripping catheter

DEVICE

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

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Varicose VeinsChronic Venous Insufficiency

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RECRUITINGNA

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

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Non-infected Venous Leg UlcerVenous Leg Ulcer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

Inclusion Criteria

Exclusion Criteria

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

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Risks and Benefits of Radiofrequency Ablation for Chronic Venous Insufficiency (CEAP C3-C6) in Patients Aged 80 and Over

THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE)

Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins