Long Term Study of 3 Radiofrequency Devices

NCT04720027 | Completed

• 1 other identifier: WorcestershireNHS
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins of Lower Limb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Absence of recurrent varicose veins and or return of symptoms

  5 years after treatment

Study Arms (3)

Closurefast

Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study

Diagnostic Test: Duplex imaging

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

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

Interventions

Duplex imaging DIAGNOSTIC_TEST

Completion of AVVQ and EQ5D questionnairs

Also known as: Completion of Quality Of Life Questionnaires

Closurefast; EndoVenous Radiofrequency (EVRF); Radiofrequency Induced Thermal Therapy (RFITT)

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Worcestershire Acute Hospitals NHS Trust: lead

Study Sites (1)

Worcestershire Acute Hospitals NHS Trust

Worcester, Worcestershire, WR5 1DD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 31351832 BACKGROUND

• 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.

  PMID: 36958479 DERIVED

Study Officials

• Isaac Nyamekye, FRCS, MD

  Worcestershire Acute Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: June 10, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 25, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)