30 Participants Needed

HIFU for Chronic Venous Insufficiency

(HIFIVE Trial)

CR
VP
Overseen ByVice President Clinical Research, Vascular Breakthroughs, LLC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sonablate
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment Sonablate HIFU System for Chronic Venous Insufficiency?

Research shows that high-intensity focused ultrasound (HIFU) can effectively close off veins in rabbits, with an 82% success rate, and can shrink human vein walls in lab studies, suggesting it may help treat venous insufficiency by improving valve function.12345

How does the Sonablate HIFU System treatment differ from other treatments for chronic venous insufficiency?

The Sonablate HIFU System is unique because it uses high-intensity focused ultrasound (HIFU) to non-invasively treat chronic venous insufficiency by targeting and occluding incompetent veins, unlike traditional invasive methods like vein stripping. This approach allows for precise thermal damage to the vein walls, potentially restoring function without the need for surgery.23467

Research Team

NN

Naiem Nassiri, MD, FSVS, RPVI

Principal Investigator

The Vascular Care Group

Eligibility Criteria

This trial is for individuals with Chronic Venous Incompetence (CVI) and related conditions like varicose veins, venous ulcers, and certain syndromes affecting veins. It's open to those who have not had success with or are seeking alternatives to more invasive treatments.

Inclusion Criteria

Ability to provide treatment consent for Sonablate HIFU energy delivery
I am 18 or older with diagnosed vein problems in my arms or legs.
Ability and willingness to remain compliant with recommended post-op follow-up
See 2 more

Exclusion Criteria

Patient unable or unwilling to provide consent
I have blood vessel abnormalities in my brain, face, head, neck, genitals, or internal organs.
Vulnerable patients
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high-intensity focused ultrasound (HIFU) ablation of incompetent veins of the periphery

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 6 hours, 24 hours, 1 week, and 4 weeks post-operatively

4 weeks
4 visits (in-person)

Treatment Details

Interventions

  • Sonablate HIFU System
Trial OverviewThe trial is testing the safety of the Sonablate High Intensity Focused Ultrasound (HIFU) System as a non-invasive treatment option for CVI and peripheral venous malformations.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Prospective observationalExperimental Treatment1 Intervention
Patients that have undergone high intensity focused ultrasound ablation of incompetent veins of the periphery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sonablate

Lead Sponsor

Trials
1
Recruited
30+

Vascular Care CT, PLLC

Collaborator

Trials
1
Recruited
30+

Vascular Breakthroughs, LLC

Collaborator

Trials
1
Recruited
30+

Findings from Research

Ultrasound-guided foam sclerotherapy (UGFS) is an effective and safe treatment for chronic venous insufficiency (CVI), showing significant improvements in quality of life and symptoms over a 1-year follow-up period in 29 patients with advanced disease (CEAP classification C4-C6).
Patients experienced notable reductions in venous filling time and great saphenous vein diameter, indicating successful treatment outcomes, with high satisfaction levels confirmed through questionnaires and ultrasound assessments.
Impact of Great Saphenous Vein Foam Sclerotherapy on Quality of Life and Photoplethysmography Findings in Chronic Venous Insufficiency: One-Year Follow-up.Neto, FC., Gomes de Oliveira, R., Thomazinho, F., et al.[2021]
High-intensity focused ultrasound (HIFU) has been shown to effectively occlude incompetent perforating veins in a non-invasive manner, achieving an 82% success rate in a study involving 15 rabbits with veins averaging 2.0 mm in diameter.
The study demonstrated that applying compression during HIFU treatment significantly enhances the effectiveness of vein occlusion, indicating a promising alternative to conventional surgical methods for treating venous insufficiency.
Noninvasive vascular occlusion with HIFU for venous insufficiency treatment: preclinical feasibility experience in rabbits.Barnat, N., Grisey, A., Lecuelle, B., et al.[2019]
The novel hand-held, battery-operated high-intensity focused ultrasound (HIFU) device effectively caused coagulation necrosis in veins, significantly reducing the luminal cross-sectional area from 3.79 mm² in controls to 0.16 mm² in treated veins, indicating its potential for effective venous ablation.
This HIFU device is noninvasive and portable, offering a simpler and more cost-effective alternative to traditional invasive treatments for varicose veins, while leaving surrounding tissues unaffected.
A portable high-intensity focused ultrasound device for noninvasive venous ablation.Henderson, PW., Lewis, GK., Shaikh, N., et al.[2012]

References

Impact of Great Saphenous Vein Foam Sclerotherapy on Quality of Life and Photoplethysmography Findings in Chronic Venous Insufficiency: One-Year Follow-up. [2021]
Noninvasive vascular occlusion with HIFU for venous insufficiency treatment: preclinical feasibility experience in rabbits. [2019]
A portable high-intensity focused ultrasound device for noninvasive venous ablation. [2012]
Testing of a HIFU probe for the treatment of superficial venous insufficiency by using MRI. [2020]
In vitro experimental study on the treatment of superficial venous insufficiency with high-intensity focused ultrasound. [2019]
Ultrasonic treatment of varicose veins. [2017]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Applying HIFU for the obliteration of the veins in the experiment ]. [2017]