Sound waves instead of surgery: new device tested for vein disease
NCT ID NCT06642051
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a device called Sonablate can safely use high-intensity focused ultrasound (HIFU) to treat vein problems like varicose veins, leg ulcers, and certain birth defects. About 30 adults with these conditions will receive the treatment, which does not involve cuts or needles. The main goal is to check for side effects like burns or blood clots within four weeks after treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients of age 18 or older with clinical and imaging evidence of venous malformations and/or venous insufficiency of the periphery 2. Lesions no deeper than 4.0cm from the skin surface 3. Lesions appropriate for and patient amenable to HIFU therapy of targeted vascular lesion/structure as determined by the principal operator and investigator 4. Ability to provide treatment consent for Sonablate HIFU energy delivery 5. Ability and willingness to remain compliant with recommended post-op follow-up Exclusion Criteria: 1. Patient unable or unwilling to provide consent 2. Patient unable or unwilling to undergo HIFU energy delivery 3. Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs 4. Patient with known vasculitis or other inflammatory vasculopathies 5. Patients with active or prior history of DVT or PE 6. Any lesion deemed unsafe by the treating surgeon or PI of the study for HIFU at the time of treatment based on clinical assessment, ultrasonographic features and/or probe positioning limitations 7. Subject who has vascular tissue targets lying \<1cm from sensitive structures or large vessels 8. Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing 9. Vulnerable patients 10. Subject with vessels \>6 mm in diameter within the vascular tissue target
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Vascular Care Group
Darien, Connecticut, 06820, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could simple leg exercises rewrite the story of chronic vein disease?
- Can a new questionnaire give patients a stronger voice in vascular malformation care?
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- VR goggles could replace sedation for vein surgery patients