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

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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins of Lower Limb
• Intervention / Treatment: Diagnostic test: Duplex imaging

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.

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• United Kingdom
  • Worcestershire
    • Worcester, Worcestershire, United Kingdom, WR5 1DD
      • Worcestershire Acute Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Closurefast; Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study	Diagnostic test: Duplex imaging; Completion of AVVQ and EQ5D questionnairs; Other Names: Completion of Quality Of Life Questionnaires
Radiofrequency Induced Thermal Therapy (RFITT); Patients who were randomised to and underwent radiofrequency ablation using the RFITT device in the original 3RF Study	Diagnostic test: Duplex imaging; Completion of AVVQ and EQ5D questionnairs; Other Names: Completion of Quality Of Life Questionnaires
EndoVenous Radiofrequency (EVRF); 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; Other Names: Completion of Quality Of Life Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Worcestershire Acute Hospitals NHS Trust
• Investigators: Principal Investigator: Isaac Nyamekye, FRCS, MD, Worcestershire Acute Hospitals NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: WorcestershireNHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No