Clinical trial NCT04384315: Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore
Official title: Pilot Study to Investigate the Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Varicose Veins
Venous Reflux
Chronic Venous Insufficiency
Keywords: Endovenous Ablation
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will be undergoing Endovenous Radio Frequency® (EVRF®) as a treatment for their varicose veins / chronic venous insufficiency

Brief summary: The aim of this study is to report a collaborative, prospective Singaporean experience using the Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

Detailed description: The investigators wish to evaluate its safety, efficacy, and performance. Although it has been shown to be safe and efficacious in its initial trials, these studies have been limited to generally a caucasian-based population, where the vein size, anatomy and distribution of venous incompetence can be different from their asian counterparts. The study will evaluate the technical, anatomical and clinical performance of EVRF® performed on multiple truncal varicose veins, and without mandatory postoperative compression stockings of the GSV, SSV or AASV. The two primary endpoints for this evaluation are technical success at the time of the procedure, and anatomical success, reported as complete closure at 2-weeks, 3 months, 6 months and 12 months.

Eligibility criteria: Inclusion Criteria:

1. Age \>21 years, able to understand the requirements of the study and provide informed consent.
2. C2 - C5 varicose veins / CVI
3. Symptomatic primaryGSV, SSV or AASV incompetence, with reflux \>0.5 seconds on colour duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling.
4. Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

Exclusion Criteria:

1. Current DVT or history of DVT
2. Recurrent varicose veins
3. Pregnant patients
4. Arterial disease (ABPI\<0.8)
5. Sepsis
6. Patients who are unwilling to participate
7. Inability or unwillingness to complete questionnaires
8. Adverse reaction to sclerosant or cyanoacrylate
9. GSV, SSV or AASV severely tortuous
10. Life expectancy \< 1 year
11. Active treatment for malignancy other than non-melanoma skin cancer
12. Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
13. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease

Primary outcomes:
measure: Technical Success at time of procedure
timeFrame: Immediately post-procedure
measure: Anatomical Success
timeFrame: 2 weeks to 12 months post-procedure
Secondary outcomes:
measure: Quality of Life Score using the EQ-5D questionnaire
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Clinical Change using Venous Clinical Severity Score (VCSS)
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Pain Score
timeFrame: First 10 days post-operation
measure: Time taken to return to work and normal activities
timeFrame: 10 days post-operation
measure: Occlusion rates
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
measure: Patient satisfaction with treatment: survey
timeFrame: 2 weeks, 3 months, 6 months, 12 months post-procedure
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapre General Hospital
state: Singaopore
Study officials:
affiliation: Singapore General Hospital
name: Tjun Yip Tang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
citation: Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
citation: van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
citation: Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.
citation: van Eekeren RR, Boersma D, de Vries JP, Zeebregts CJ, Reijnen MM. Update of endovenous treatment modalities for insufficient saphenous veins--a review of literature. Semin Vasc Surg. 2014 Jun;27(2):118-36. doi: 10.1053/j.semvascsurg.2015.02.002. Epub 2015 Feb 18.
citation: Guex JJ. Endovenous chemical (and physical) treatments for varices: what's new? Phlebology. 2014 May;29(1 suppl):45-48. doi: 10.1177/0268355514526331. Epub 2014 May 19.
citation: Davies HO, Popplewell M, Darvall K, Bate G, Bradbury AW. A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins. Phlebology. 2016 May;31(4):234-40. doi: 10.1177/0268355515595194. Epub 2015 Jul 9.