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

NCT ID: NCT04384315

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2022-12-01

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.

Conditions

Varicose Veins; Venous Reflux; Chronic Venous Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Questionnaires

Intervention Type: OTHER

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

Interventions

Questionnaires

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tjun Yip Tang

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

Singapre General Hospital

Singapore, Singaopore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Charyl Yap

Role: CONTACT

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

65767986

Facility Contacts

Charyl Yap

Role: primary

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

65767986

References

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Reference Type: BACKGROUND

PMID: 21536172 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15723761 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 18692348 (View on PubMed)

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Reference Type: 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.

Reference Type: BACKGROUND

PMID: 25868763 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24843085 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26163507 (View on PubMed)

Other Identifiers

2019/2544

Identifier Type: -

Identifier Source: org_study_id