Varicose Veins of Lower Limb3RF-5YearsNCT04720027
Long Term Study of 3 Radiofrequency Devices
An observational study of Varicose Veins of Lower Limb, run by Worcestershire Acute Hospitals NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 23 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Duplex imaging
- How many people
- 117 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jun 2021to 25 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The 180 patients who were originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Worcestershire Acute Hospitals NHS Trust
Worcester, Worcestershire, WR5 1DD
About this study
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
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.
Read the 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.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Duplex imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplex imagingDiagnostic test
Also called Completion of Quality Of Life Questionnaires
Completion of AVVQ and EQ5D questionnairs
| Study group | Role | What they receive |
|---|---|---|
| Closurefast | Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study Receives: 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 Receives: 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 Receives: Diagnostic Test: Duplex imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years after treatment
Secondary outcomes (1)
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.
Measured: 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start10 Jun 2021
- Primary completion31 Mar 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Worcestershire Acute Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Nyamekye, FRCS, MD, Principal investigator, Worcestershire Acute Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720027
- Sponsor's protocol ID
- WorcestershireNHS
- Acronym
- 3RF-5Years
- Status last verified
- Aug 2022
- First submitted
- 18 Jan 2021
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not plan to share IPD
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.
PubMed 31351832Nyamekye 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.
PubMed 36958479
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04720027
- Acronym / sponsor ID
- 3RF-5Years / WorcestershireNHS
- Conditions
- Varicose Veins of Lower Limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Worcestershire Acute Hospitals NHS TrustUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closurefast | – | Diagnostic Test: Duplex imagingPatients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study |
| Radiofrequency Induced Thermal Therapy (RFITT) | – | Diagnostic Test: Duplex imagingPatients who were randomised to and underwent radiofrequency ablation using the RFITT device in the original 3RF Study |
| EndoVenous Radiofrequency (EVRF) | – | Diagnostic Test: Duplex imagingPatients who were randomised to and underwent radiofrequency ablation using the EVRF device in the original 3RF Study |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The 180 patients who were originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881)
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duplex imagingAlso: Completion of Quality Of Life QuestionnairesCompletion of AVVQ and EQ5D questionnairs | Diagnostic test | Closurefast, EndoVenous Radiofrequency (EVRF), Radiofrequency Induced Thermal Therapy (RFITT) |
Primary outcome
Anatomical assessment of ablation of treated GSV segment
Time frame: 5 years after treatment
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.
1 secondary outcome
Absence of recurrent varicose veins and or return of symptoms
Time frame: 5 years after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Background: PubMed 31351832Nyamekye 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.
- Derived from this study: PubMed 36958479Nyamekye 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.
- Individual participant dataSharing planned: No. There is not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Nyamekye, FRCS, MD principal investigator
Worcestershire Acute Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins of Lower Limb, run by Worcestershire Acute Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomical assessment of ablation of treated GSV segment (time frame: 5 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720027, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.