An interventional study of Sonovein Treatment in Chronic Venous Insufficiency, sponsored by Theraclion. Completed at 4 sites in 3 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Theraclion · Not applicable, Interventional, and Treatment
This is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary GSV insufficiency. Patients will be consented at a Pre-Study Visit and evaluated for eligibility and for baseline characteristics of the disease. Patients will receive treatment with Sonovein for the targeted segments of GSV. At follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported VAS evaluations. Continued follow-up for a total of 12 months will be completed prior to subject study exit. Adverse events (AE) will be assessed at every study visit following HIFU treatment.
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
This study's enrollment of 70 is below the median of 101 across 154 interventional studies indexed under Varicose Veins.
Browse Varicose Veins studies →Theraclion is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Sonovein Treatment
The Sonovein System provides High Intensity Focused Ultrasound (HIFU) ablation of soft tissue. The energy is delivered via an extra-corporeal treatment probe, which includes an imaging system. The high-energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue. The process is then repeated in a stepwise fashion.
Vein Occlusion Rate
Percentage of limbs with occlusion of the treated vein (as measured by Duplex ultrasound)
Time frame: 12 months
Complications
Number of limbs presenting complications and side effects resulting from the GSV intervention
Time frame: 12 months
Reflux-free Rate
Percentage of limbs without reflux in the treated vein (as measured by Duplex ultrasound)
Time frame: 12 months
Venous Clinical Severity Score (VCSS)
Assessment of venous disease (Scale 0-30: MIN=0 (least severe); MAX=30 (most severe))
Time frame: 12 months
Clinical-Etiology-Anatomy-Pathophysiology (CEAP)
Clinical signs and symptoms of lower limb venous disease (Scale C0-C6: MIN: C0=no visible or palpable signs of venous disease; MAX: C6=active venous ulcer)
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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