Chronic Venous Insufficiency, CVIHIFIVENCT06642051
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
A study testing High Intensity focused ultrasound in people with Chronic Venous Insufficiency, CVI and Venous Malformations, run by Sonablate at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the periphery meaning legs, abdomen, chest or back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers
- What is being tested?
- High Intensity focused ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of age 18 or older with clinical and imaging evidence of venous malformations and/or venous insufficiency of the periphery
- Lesions no deeper than 4.0cm from the skin surface
- Lesions appropriate for and patient amenable to HIFU therapy of targeted vascular lesion/structure as determined by the principal operator and investigator
- Ability to provide treatment consent for Sonablate HIFU energy delivery
- Ability and willingness to remain compliant with recommended post-op follow-up
Who cannot join
- Patient unable or unwilling to provide consent
- Patient unable or unwilling to undergo HIFU energy delivery
- Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
- Patient with known vasculitis or other inflammatory vasculopathies
- Patients with active or prior history of DVT or PE
- 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
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- Subject who has vascular tissue targets lying \<1cm from sensitive structures or large vessels
- Women who are pregnant or planning to become pregnant prior to procedure or within the 30-day study period, or nursing
- Vulnerable patients
- Subject with vessels \>6 mm in diameter within the vascular tissue target
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of the Sonablate System for the High-Intensity Focused Ultrasound (HIFU) Ablation of Incompetent Veins of the Periphery
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the periphery meaning legs, abdomen, chest or back. Examples of CVI are varicose veins, vascular congestion, venous ulcer, venous clusters, venous anomalies, mixed malformation, Klippel-Trenaunay Syndrome, CLOVES, Syndrome, Blue Rubber bleb Nevus Syndrome. HIFU is a non-invasive treatment as opposed to current treatment options which include incisions, needle penetration, wire insertions or catheter insertions.
Read the detailed description
The Sonablate High Intensity Focused Ultrasound (HIFU) system is a non-invasive technology that uses focused ultrasound waves to ablate targeted tissue within the body without ionizing radiation or surgical excision. Through the precise delivery of ultrasonic waves, HIFU rapidly elevates the temperature in the targeted tissue, leading to the disruption of lipid membranes, denaturation of proteins, destruction of vascular endothelial cells and ultimately coagulative necrosis without damage to the overlying tissue. This device is cleared by the FDA for the ablation of prostate tissue.
This is a single arm, single institution, Phase one trial of 30 patients planned to last 18 months. The primary endpoint is to assess the 30-day safety profile and technical feasibility of using the Sonablate high-intensity focused ultrasound (HIFU) system for ablating incompetent veins of the periphery. This includes vascular malformations, varicose veins and incompetent superficial veins.
- Conditions
- Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome, CLOVES Syndrome, Blue Rubber Bleb Nevus Syndrome
- Being tested
- High Intensity focused ultrasound
- Keywords
- High Intensity focused ultrasound, venous closure, endovenous ablation
- Medical subject headings
- Blindness, Cortical, Klippel-Trenaunay-Weber Syndrome, Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi, Blue rubber bleb nevus syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity focused ultrasoundDevice
Also called Venous ablation
Sonablate High Intensity Focused Ultrasound system to ablate incompetent veins of the periphery
| Study group | Role | What they receive |
|---|---|---|
| Prospective observational | Experimental | Patients that have undergone high intensity focused ultrasound ablation of incompetent veins of the periphery Receives: Device: High Intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery.
Safety as measured by the magnitude and frequency of adverse events from HIFU. This includes any burns, scalds, blistering and hyperemic changes on physical exam intraoperatively, at 6h, 24h, 1w, and 4 weeks post-operatively; worsening limb pain and swelling due to DVT diagnosed with Duplex Ultrasound within 4 weeks post-operatively; sensory nerve injury via formal neurological examination at 6h, 1w, and 4 weeks post-operatively.
Measured: 30 days
Secondary outcomes (1)
Short-term efficacy and technical feasibility of using the Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery
Real-time B mode ultrasound imaging of HIFU to vascular tissue to evaluate the ultrasonographic changes in the targeted vessels and immediately adjacent tissues. Intraoperative duplex ultrasound of the targeted veins to quantify vessel closure rates or thrombosis immediately after HIFU delivery. Post-operative duplex ultrasound or magnetic resonance imaging of the targeted veins during follow up at 1 week and 4 weeks to assess vessel closure rates or thrombosis of target veins.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start11 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Insufficiency, CVIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The use of High Intensity Focused Ultrasound for the ablation of incompetent veins of the periphery.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonablate
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vascular Care CT, PLLC, Vascular Breakthroughs, LLC
- Responsible party
- Sponsor
- Investigators
- Naiem Nassiri, MD, FSVS, RPVI, Principal investigator, The Vascular Care Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642051
- Sponsor's protocol ID
- 20243482
- Acronym
- HIFIVE
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the Sonablate System for the High-Intensity Focused Ultrasound (HIFU) Ablation of Incompetent Veins of the Periphery
- ClinicalTrials.gov ID
- NCT06642051
- Acronym / sponsor ID
- HIFIVE / 20243482
- Conditions
- Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome, CLOVES Syndrome, Blue Rubber Bleb Nevus Syndrome
- Keywords
- High Intensity focused ultrasound, venous closure, endovenous ablation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SonablateIndustry (pharma, biotech, devices)
- Collaborators
- Vascular Care CT, PLLC, Vascular Breakthroughs, LLC
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the Sonablate High Intensity Focused Ultrasound device can be safely used to treat patients with Chronic Venous Incompetence (CVI) including those with venous malformations of the periphery meaning legs, abdomen, chest or back. Examples of CVI are varicose veins, vascular congestion, venous ulcer, venous clusters, venous anomalies, mixed malformation, Klippel-Trenaunay Syndrome, CLOVES, Syndrome, Blue Rubber bleb Nevus Syndrome. HIFU is a non-invasive treatment as opposed to current treatment options which include incisions, needle penetration, wire insertions or catheter insertions.
Detailed description
The Sonablate High Intensity Focused Ultrasound (HIFU) system is a non-invasive technology that uses focused ultrasound waves to ablate targeted tissue within the body without ionizing radiation or surgical excision. Through the precise delivery of ultrasonic waves, HIFU rapidly elevates the temperature in the targeted tissue, leading to the disruption of lipid membranes, denaturation of proteins, destruction of vascular endothelial cells and ultimately coagulative necrosis without damage to the overlying tissue. This device is cleared by the FDA for the ablation of prostate tissue.
This is a single arm, single institution, Phase one trial of 30 patients planned to last 18 months. The primary endpoint is to assess the 30-day safety profile and technical feasibility of using the Sonablate high-intensity focused ultrasound (HIFU) system for ablating incompetent veins of the periphery. This includes vascular malformations, varicose veins and incompetent superficial veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The use of High Intensity Focused Ultrasound for the ablation of incompetent veins of the periphery.
| Arm | Type | Receives |
|---|---|---|
| Prospective observational | Experimental | Device: High Intensity focused ultrasoundPatients that have undergone high intensity focused ultrasound ablation of incompetent veins of the periphery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients of age 18 or older with clinical and imaging evidence of venous malformations and/or venous insufficiency of the periphery
- Lesions no deeper than 4.0cm from the skin surface
- Lesions appropriate for and patient amenable to HIFU therapy of targeted vascular lesion/structure as determined by the principal operator and investigator
- Ability to provide treatment consent for Sonablate HIFU energy delivery
- Ability and willingness to remain compliant with recommended post-op follow-up
Key exclusion criteria (10 listed)
- Patient unable or unwilling to provide consent
- Patient unable or unwilling to undergo HIFU energy delivery
- Patient with vascular lesions involving the central nervous system, face, head, and neck, genitalia, visceral or internal organs
- Patient with known vasculitis or other inflammatory vasculopathies
- Patients with active or prior history of DVT or PE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity focused ultrasoundAlso: Venous ablationSonablate High Intensity Focused Ultrasound system to ablate incompetent veins of the periphery | Device | Prospective observational |
Primary outcome
Safety of Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery.
Time frame: 30 days
Safety as measured by the magnitude and frequency of adverse events from HIFU. This includes any burns, scalds, blistering and hyperemic changes on physical exam intraoperatively, at 6h, 24h, 1w, and 4 weeks post-operatively; worsening limb pain and swelling due to DVT diagnosed with Duplex Ultrasound within 4 weeks post-operatively; sensory nerve injury via formal neurological examination at 6h, 1w, and 4 weeks post-operatively.
1 secondary outcome
Short-term efficacy and technical feasibility of using the Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Vascular anomalies and malformation program patient information websiteLink provided by the sponsor.
- Resource for information on vascular birthmarks, anomalies and related symptoms.Link provided by the sponsor.
- Comprehensive online information on the Sonablate high intensity focused ultrasound probe.Link provided by the sponsor.
- Comprehensive source of information for vast array of clinical applications for focused ultrasound therapyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naiem Nassiri, MD, FSVS, RPVI principal investigator
The Vascular Care Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity focused ultrasound in people with Chronic Venous Insufficiency, CVI and Venous Malformations, run by Sonablate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.