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

NCT04384315 | Unknown

• 1 other identifier: 2019/2544
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins; Venous Reflux; Chronic Venous Insufficiency

Keywords

Endovenous Ablation

Outcome Measures

Primary Outcomes (2)

• Technical Success at time of procedure

  Occlusion of treated vein post-procedure

  Immediately post-procedure

• Anatomical Success

  Anatomical success defined as occlusion of treated vessel, as determined by duplex ultrasound.

  2 weeks to 12 months post-procedure

Secondary Outcomes (8)

• Quality of Life Score using the EQ-5D questionnaire

  2 weeks, 3 months, 6 months, 12 months post-procedure

• Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)

  2 weeks, 3 months, 6 months, 12 months post-procedure

• Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)

  2 weeks, 3 months, 6 months, 12 months post-procedure

• Clinical Change using Venous Clinical Severity Score (VCSS)

  2 weeks, 3 months, 6 months, 12 months post-procedure

• Pain Score

  First 10 days post-operation

Study Arms (1)

EVRF

Patients that have undergone Endovenous Radio Frequency® (EVRF®) from F Care Systems (Belgian) for the treatment of primary great and short saphenous vein reflux.

Other: Questionnaires

Interventions

Questionnaires OTHER

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

EVRF

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age \>21 years, able to understand the requirements of the study and provide informed consent.
• C2 - C5 varicose veins / CVI
• 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.
• Patients who has GSV, SSV or AASV diameters of 3mm to 12mm in the standing position.

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapre General Hospital

Singapore, Singaopore, 169608, Singapore

RECRUITING

Related Publications (7)

• 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.

  PMID: 21536172 BACKGROUND

• 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.

  PMID: 15723761 BACKGROUND

• 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.

  PMID: 18692348 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 25868763 BACKGROUND

• 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.

  PMID: 24843085 BACKGROUND

• 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.

  PMID: 26163507 BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tjun Yip Tang

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap

CONTACT

65767986; charyl.yap.j.q@sgh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: May 12, 2020
• Study Start: August 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)