Clinical trial NCT04720027: Long Term Study of 3 Radiofrequency Devices
Official title: Long Term Outcomes of the Double Blind Randomised Controlled Trial of Radiofrequency Thermal Ablation Treatments of Great Saphenous Varicose Veins: Closurefast vs. RFITT vs. EVRF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins of Lower Limb
Lead sponsor: Worcestershire Acute Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 117
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The 180 patients who were originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anatomical assessment of ablation of treated GSV segment
timeFrame: 5 years after treatment
Secondary outcomes:
measure: Absence of recurrent varicose veins and or return of symptoms
timeFrame: 5 years after treatment
Other outcomes:
Locations:
city: Worcester
country: United Kingdom
facility: Worcestershire Acute Hospitals NHS Trust
state: Worcestershire
Study officials:
affiliation: Worcestershire Acute Hospitals NHS Trust
name: Isaac Nyamekye, FRCS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.