Long Term Study of 3 Radiofrequency Devices

Varicose Veins of Lower Limb Clinical Trial

— 3RF-5Years  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720027
• Other study ID #: WorcestershireNHS
• Status: Completed
• Start date: June 10, 2021
• Est. completion date: June 25, 2022

Study information

• Verified date: August 2022
• Source: Worcestershire Acute Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 25, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Diagnostic Test:
• Duplex imaging
Completion of AVVQ and EQ5D questionnairs

Locations

Country	Name	City	State
United Kingdom	Worcestershire Acute Hospitals NHS Trust	Worcester	Worcestershire

Sponsors (1)

Lead Sponsor	Collaborator
Worcestershire Acute Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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