An observational study in Varicose Veins of Lower Limb, sponsored by Worcestershire Acute Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 23 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-15.
Sponsored by Worcestershire Acute Hospitals NHS Trust · Observational
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.
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.
253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.
This study's enrollment of 117 is close to the median of 124 across 79 observational studies indexed under Varicose Veins.
Browse Varicose Veins studies →Worcestershire Acute Hospitals NHS Trust is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The 180 patients who were originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881)
Exclusion Criteria:
Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study
Diagnostic Test: Duplex imaging
Patients who were randomised to and underwent radiofrequency ablation using the RFITT device in the original 3RF Study
Diagnostic Test: Duplex imaging
Patients who were randomised to and underwent radiofrequency ablation using the EVRF device in the original 3RF Study
Diagnostic Test: Duplex imaging
Completion of AVVQ and EQ5D questionnairs
Also known as: Completion of Quality Of Life Questionnaires
Anatomical assessment of ablation of treated GSV segment
Aanatomical assessment of total ablation of treated segment will be assessed: Failure will be defined as any segment of the treated trunk (\> 2cm from the saphenofemoral junction) that is patent (compressible) and demonstrates reflux (\>1 second) on duplex scanning.
Time frame: 5 years after treatment
Absence of recurrent varicose veins and or return of symptoms
Assessments using disease specific (AVVQ) and generic (EQ5D) quality of life scores by means of self-completed questionnaires completed at a single consultation.
Time frame: 5 years after treatment
Plan to share: No — There is not plan to share IPD
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Worcestershire Acute Hospitals NHS Trust