HIFU for Chronic Venous Insufficiency

(HIFIVE Trial)

Overseen By Vice President Clinical Research, Vascular Breakthroughs, LLC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonablate

Disqualifiers: Vasculitis, DVT, PE, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a non-invasive treatment called High Intensity Focused Ultrasound (HIFU) can safely assist individuals with Chronic Venous Insufficiency (CVI), a condition affecting blood flow in the legs, abdomen, chest, or back. CVI can cause issues like varicose veins and venous ulcers. The treatment aims to alleviate these symptoms without surgery or needles, which are common in current procedures. Individuals with long-standing CVI and lesions near the skin's surface might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to investigate a promising treatment option for CVI without the invasiveness of traditional methods.

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 prior data suggests that the Sonablate HIFU System is safe for treating Chronic Venous Insufficiency?

Research has shown that high-intensity focused ultrasound (HIFU) is generally safe for treating vein problems. In studies, HIFU successfully closed veins in animals, achieving an 82% success rate. For humans, HIFU has also reduced vein size without surgery.

Additionally, HIFU effectively blocks veins as a non-invasive treatment, avoiding cutting or needles. These findings suggest that HIFU is well-tolerated and could be a safer option compared to more invasive procedures for treating chronic venous insufficiency (CVI), including conditions like varicose veins and venous ulcers.

These studies focus on safety, and future trials will provide more information on its effectiveness for different conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Sonablate HIFU System is unique because it uses high intensity focused ultrasound (HIFU) to treat chronic venous insufficiency, a condition where veins have trouble sending blood from the legs back to the heart. Traditional treatments often involve surgery or thermal ablation, which can be invasive and require recovery time. In contrast, HIFU is non-invasive and precisely targets the incompetent veins without affecting surrounding tissues. Researchers are excited about this treatment because it offers a potentially safer and more comfortable option with minimal downtime for patients.

What evidence suggests that the Sonablate HIFU System is effective for treating Chronic Venous Insufficiency?

Research has shown that high-intensity focused ultrasound (HIFU) can effectively close off veins. In studies on rabbits, HIFU successfully shut down veins 82% of the time. In humans, it has been shown to shrink veins and stop blood from leaking backward, a condition known as high leak point occlusion. This trial will evaluate the Sonablate HIFU System for treating chronic venous insufficiency (CVI) in humans. This non-invasive method shows promise for treating conditions like varicose veins and venous ulcers without surgery or needles. Overall, early findings suggest HIFU could be a safe and effective option for people with CVI. ^{1 2 3 4 5}

Who Is on the Research Team?

Naiem Nassiri, MD, FSVS, RPVI

Principal Investigator

The Vascular Care Group

Are You a Good Fit for This Trial?

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

Ability and willingness to remain compliant with recommended post-op follow-up

I am 18 or older with diagnosed vein problems in my arms or legs.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Sonablate HIFU System

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Prospective observational Experimental Treatment 1 Intervention

Patients that have undergone high intensity focused ultrasound ablation of incompetent veins of the periphery

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable high-intensity focused ultrasound device for noninvasive venous ablation. Henderson, PW., Lewis, GK., Shaikh, N., et al.[2012]

Focused high-intensity ultrasound has shown promising results in destroying the venous wall in both experimental dogs and patients with varicose veins, indicating its potential as a treatment option.

This non-invasive approach could provide an effective alternative to traditional invasive procedures for treating varicose veins and other venous disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonic treatment of varicose veins. Schultz-Haakh, H., Li, JK., Welkowitz, W., et al.[2017]

High-intensity focused ultrasound (HIFU) caused significant structural changes in the venous wall of rabbits, including endothelial desquamation and collagen fiber coagulation, indicating its potential for targeted vascular treatments.

The study revealed that HIFU exposure can lead to local temperature increases up to ~60°C, resulting in acute muscle injury and inflammation in surrounding tissues, which highlights the need for careful application to avoid unintended damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Applying HIFU for the obliteration of the veins in the experiment ]. Petrishchev, NN., Tsibin, AU., Semenov, DU., et al.[2017]

A new high intensity focused ultrasound (HIFU) probe has been developed to treat valvular dysfunction in the saphenous vein, which can help alleviate superficial venous insufficiency and varicose veins.

In vitro tests show that the HIFU treatment can effectively shrink venous tissue enough to restore proper valve function, and the probe design has been validated through pressure and temperature measurements that align with predictions from simulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing of a HIFU probe for the treatment of superficial venous insufficiency by using MRI. Angel, YC., Pichardo, S., Salomir, R., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 can effectively shrink collagen fibers in the walls of the great saphenous vein, potentially curing dilation that leads to valvular dysfunction and superficial venous insufficiency, as demonstrated in an in vitro study of 20 human vein segments.

The treatment showed a contraction index of 7% to 24% retraction without causing any damage to the vein, such as rupture or perforation, indicating a safe and effective method for addressing venous insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro experimental study on the treatment of superficial venous insufficiency with high-intensity focused ultrasound. Pichardo, S., Milleret, R., Curiel, L., et al.[2019]

Citations

1.

sonablate.com

sonablate.com/news-press/sonablate-announces-first-patient-enrolled-in-hifive-u-s-clinical-trial-for-ablation-of-incompetent-veins

In Sonablate News

HIFIVE is a single arm, single institution, Phase I trial to assess the safety and performance of Sonablate high-intensity focused ultrasound for treating ...

2.

withpower.com

withpower.com/trial/phase-venous-insufficiency-8-2024-ea31a

HIFU for Chronic Venous Insufficiency (HIFIVE Trial)

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 ...

3.

fusfoundation.org

fusfoundation.org/posts/focused-ultrasound-clinical-trial-begins-for-venous-disease-including-vascular-malformations/

Focused Ultrasound Clinical Trial Begins for Venous ...

The clinical trial seeks to address deep and superficial venous reflux, varicose veins, venous ulcers, and vascular malformations.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40118271/

High-intensity-focused ultrasound treatment for the chronic ...

Conclusions: HIFU achieves high leak point occlusion rates when applied under CHIVA principles, supporting its role as an effective and safe noninvasive ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06642051?cond=Blue%20rubber%20bleb%20nevus&viewType=Table&rank=2

Safety of the Sonablate HIFU System for the Ablation ...

Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...