Long Term Study of 3 Radiofrequency Devices (3RF-5Years)

Worcestershire Acute Hospitals NHS Trust

Status

Completed

Conditions

Varicose Veins of Lower Limb

Treatments

Diagnostic Test: Duplex imaging

Study type

Observational

Funder types

Other

Identifiers

NCT04720027

WorcestershireNHS

Details and patient eligibility

About

To establish which of the radiofrequency venous ablation modalities studied in the original 3RF study (Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (GSV)) 5 years following surgery.

Full description

Results of randomised trials and meta-analyses have shown that endovenous thermal ablation of the GSV using radiofrequency ablation or laser is associated with improved recovery compared with conventional surgery. Furthermore, radiofrequency ablation (using the Closurefast device) has been shown to cause less pain and require less analgesic intake than laser treatment. At the time the 3 RF study was conceived there were two other radiofrequency devices that were marketed to have theoretical advantages over the Closurefast technique. All three devices were in use in clinical practice (including at Worcestershire Royal Hospital) in 2013. The initial study focused on clinical results (up to 12 months) and anatomical results (up to 6 months) and remains the only clinical trial to date that has directly compared the outcomes of radiofrequency thermal ablation devices.

This second (long term) phase of the study aims to assess which of the radiofrequency venous ablation modalities studied in the original 3RF study (Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (GSV)) 5 years following surgery.

Enrollment

117 patients

Sex

All

Ages

23+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881) who give informed consent to take part in this long term study

Exclusion criteria

Patients originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881) who do not give informed consent to take part in this long term study