High Intensity Focused Ultrasound in PAtients With Varicose Veins in Singapore

NCT ID: NCT04339088

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-12-01

Brief Summary

The aim of the study is to evaluate the efficacy of non-invasive echotherapy for the treatment of varicose veins, within local population, using the Sonovein® device. The quality of life scores at baseline, 2 weeks, 3 months, 6 months and 12 months will be assessed using the EQ-50D, AVVQ and CIVIQ scores. Patient satisfaction at these time points will also be assessed.

Detailed Description

Sonovein® is a unique echotherapy solution, combining therapeutic ultrasound and ultrasound for monitoring. The high-intensity ultrasound beam is focused on the vein through a magnifying glass. As thermal energy is delivered, the thermocoagulation property of ultrasound energy affects the vein wall, causing shrinking and collapsing of the target vein. Thus creating a fibrotic seal and occluding the vessel. The treated vein is immediately closed after the procedure, and its diameter will continuously reduce over time, becoming a fibrotic chord. The treatment along the vein is steered automatically via a touch screen monitor. In-beam linear ultrasound probe allows visualisation of the vein in real-time and insures optimal accuracy. The study involves prospective data collection of 30 patients that will be undergoing HIFU as choice of treatment for their varicose veins / CVI. Questionnaires will be conducted at 5 timepoints - baseline before procedure, 2 weeks, 3 months, 6 months and 12 months. Subjects will be seen at outpatient clinic post-procedure. Besides questionnaires, physical examination and duplex ultrasound scan will be conducted at 2 weeks, 3 months, 6 months and 12 months to ensure occlusion of treated vein.

Conditions

Varicose Veins; Venous Reflux; Chronic Venous Insufficiency

Study Design

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

Study Groups

HIFU

Patients that have undergone high focused ultrasound treatment for varicose veins

Questionnaires

Intervention Type: OTHER

Questionnaires to assess quality of life

Interventions

Questionnaires

Questionnaires to assess quality of life

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 primary GSV, 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, , Singapore

Countries

Singapore

Central Contacts

Charyl Yap

Role: CONTACT

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

65767986

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 11207682 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19879166 (View on PubMed)

Other Identifiers

2019/2933

Identifier Type: -

Identifier Source: org_study_id