Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore

Varicose Veins Clinical Trial

— ESVS  

Official title:

Pilot Study to Investigate the Efficacy and Safety of Endovenous Radio Frequency (EVRF) for Treatment of Varicose Veins in Singapore

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384315
• Other study ID #: 2019/2544
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: Singapore General Hospital
• Contact: Charyl Yap
• Phone: 65767986
• Email: charyl.yap.j.q[@]sgh.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Varicose Veins
• Venous Insufficiency
• Venous Reflux

Intervention

Other:
• Questionnaires
Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)

Locations

Country	Name	City	State
Singapore	Singapre General Hospital	Singapore	Singaopore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (7)

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. Review. — View 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. Review. — View Citation

Geza M, Gloviczki P. Venous Embryology and Anatomy. In: Bergan JJ, editor. The Vein Book: Elsivier Academic Press; 2007.

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. — View Citation

Guex JJ. Endovenous chemical (and physical) treatments for varices: what's new? Phlebology. 2014 May;29(1 suppl):45-48. Epub 2014 May 19. Review. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical Success at time of procedure	Occlusion of treated vein post-procedure	Immediately post-procedure
Primary	Anatomical Success	Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound.	2 weeks to 12 months post-procedure
Secondary	Quality of Life Score using the EQ-5D questionnaire	EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)	CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)	To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Clinical Change using Venous Clinical Severity Score (VCSS)	VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Pain Score	Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)	First 10 days post-operation
Secondary	Time taken to return to work and normal activities		10 days post-operation
Secondary	Occlusion rates	Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Patient satisfaction with treatment: survey	A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure.	2 weeks, 3 months, 6 months, 12 months post-procedure