Varicose Veins of Lower Limb Clinical Trial
— 3RF-5YearsOfficial 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
Verified date | August 2022 |
Source | Worcestershire Acute Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Worcestershire Acute Hospitals NHS Trust | Worcester | Worcestershire |
Lead Sponsor | Collaborator |
---|---|
Worcestershire Acute Hospitals NHS Trust |
United Kingdom,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05930587 -
Effect of Cold Immersion on Patients With Varicose Vein
|
N/A | |
Recruiting |
NCT04546750 -
Prospective Cohort Study for Varicose Veins Incidence and Natural Course
|
||
Completed |
NCT05372146 -
Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients
|
N/A | |
Recruiting |
NCT06124664 -
Study of Venous Outflow From the Lower Limbs in Patients With Pelvic Varicosities
|
||
Completed |
NCT03613376 -
Compression And Functional Ability After Endovenous Varicose Vein Treatment
|
N/A | |
Completed |
NCT04148950 -
Effects of Kinesio Taping Method on Functional Capacity and Quality of Life in Patients With Chronic Venous Disease
|
N/A | |
Completed |
NCT04658901 -
ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China
|
N/A | |
Not yet recruiting |
NCT04794712 -
Evaluation of Pain Associated With Chronic Venous Insufficiency
|
||
Recruiting |
NCT05581524 -
Vacuum Assisted Sclerotherapy Performed by Catheter
|
N/A | |
Completed |
NCT05058989 -
The Evaluation of the Pathophysiology of Varicose Veins in Pregnancy
|
||
Recruiting |
NCT03035747 -
Ongoing Registry of Treatment of Chronic Venous Diseases
|
||
Recruiting |
NCT05851183 -
Effect of Vitis Vinifera Seed Extract on Venous Reflux Time in Varicose Vein
|
Phase 4 | |
Completed |
NCT05468450 -
RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency
|
N/A | |
Completed |
NCT03722134 -
Mechanochemical Ablation vs Thermal Ablation
|
N/A | |
Active, not recruiting |
NCT04726124 -
MicrOwave and laSer ablaTion Study (MOST Study)
|
N/A | |
Active, not recruiting |
NCT06387264 -
Compont - Varicose Veins of the Lower Extremities
|
N/A | |
Recruiting |
NCT03293836 -
Venous Ulcer: Endovenous Radiofrequency Treatment Trial
|
N/A | |
Recruiting |
NCT04645771 -
Safety and Efficacy Study of Endovenous Microwave Ablation for Treatment of Varicose Veins
|
N/A | |
Enrolling by invitation |
NCT06175546 -
Daily Duration of Compression Treatment in Patients With Symptomatic Chronic Venous Disease
|
N/A | |
Not yet recruiting |
NCT05654233 -
The Study of Reducing Adverse Effects After Radiofrequency Ablation Combined With Sclerotherapy
|
N/A |