Long Term Study of 3 Radiofrequency Devices
- Conditions
- Varicose Veins of Lower Limb
- Interventions
- Diagnostic Test: Duplex imaging
- Registration Number
- NCT04720027
- Lead Sponsor
- Worcestershire Acute Hospitals NHS Trust
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Closurefast Duplex imaging Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study Radiofrequency Induced Thermal Therapy (RFITT) Duplex imaging Patients who were randomised to and underwent radiofrequency ablation using the RFITT device in the original 3RF Study EndoVenous Radiofrequency (EVRF) Duplex imaging Patients who were randomised to and underwent radiofrequency ablation using the EVRF device in the original 3RF Study
- Primary Outcome Measures
Name Time Method Anatomical assessment of ablation of treated GSV segment 5 years after treatment 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.
- Secondary Outcome Measures
Name Time Method Absence of recurrent varicose veins and or return of symptoms 5 years after treatment Assessments using disease specific (AVVQ) and generic (EQ5D) quality of life scores by means of self-completed questionnaires completed at a single consultation.
Trial Locations
- Locations (1)
Worcestershire Acute Hospitals NHS Trust
🇬🇧Worcester, Worcestershire, United Kingdom