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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closurefast | Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study |
| |
| Radiofrequency Induced Thermal Therapy (RFITT) | Patients who were randomised to and underwent radiofrequency ablation using the RFITT device in the original 3RF Study |
| |
| EndoVenous Radiofrequency (EVRF) | Patients who were randomised to and underwent radiofrequency ablation using the EVRF device in the original 3RF Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duplex imaging | Diagnostic Test | Completion of AVVQ and EQ5D questionnairs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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The 180 patients who were originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881)
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Nyamekye, FRCS, MD | Worcestershire Acute Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worcestershire Acute Hospitals NHS Trust | Worcester | Worcestershire | WR5 1DD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31351832 | Background | Nyamekye IK, Dattani N, Hayes W, Harding D, Holloway S, Newman J. A Randomised Controlled Trial Comparing Three Different Radiofrequency Technologies: Short-Term Results of the 3-RF Trial. Eur J Vasc Endovasc Surg. 2019 Sep;58(3):401-408. doi: 10.1016/j.ejvs.2019.01.033. Epub 2019 Jul 24. | |
| 36958479 | Derived |
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There is not plan to share IPD
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2023 | |
| Reset | May 31, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2023 | May 31, 2024 |
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| Nyamekye IK, Pullen BJ, Kelly N, Hayes W. Six Year Extension Study of Patients From a Randomised Clinical Trial Comparing Venefit, Radiofrequency Induced Thermal Therapy, and Endovenous Radiofrequency Ablation for Treatment of Incompetent Great Saphenous Veins. Eur J Vasc Endovasc Surg. 2023 Jul;66(1):94-101. doi: 10.1016/j.ejvs.2023.03.021. Epub 2023 Mar 21. |