Long Term Study of 3 Radiofrequency Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-10

Study Completion Date

2022-06-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Varicose Veins of Lower Limb

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Closurefast

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

Duplex imaging

Intervention Type DIAGNOSTIC_TEST

Completion of AVVQ and EQ5D questionnairs

Radiofrequency Induced Thermal Therapy (RFITT)

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

Duplex imaging

Intervention Type DIAGNOSTIC_TEST

Completion of AVVQ and EQ5D questionnairs

EndoVenous Radiofrequency (EVRF)

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

Duplex imaging

Intervention Type DIAGNOSTIC_TEST

Completion of AVVQ and EQ5D questionnairs

Interventions

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Duplex imaging

Completion of AVVQ and EQ5D questionnairs

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Completion of Quality Of Life Questionnaires

Eligibility Criteria

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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

Minimum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes