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Procedure

HIFU for Chronic Venous Insufficiency (HIFIVE Trial)

N/A

Recruiting

Led By Naiem Nassiri, MD, FSVS, RPVI

Research Sponsored by Sonablate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patient with known vasculitis or other inflammatory vasculopathies

Patients with active or prior history of DVT or PE

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a non-invasive device called Sonablate High Intensity Focused Ultrasound can safely treat patients with Chronic Venous Incompetence (CVI), which includes conditions

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation, pain at the treatment site, swelling, bruising, or burns due to focused ultrasound energy. However, HIFU aims to be less invasive than traditional methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My cancer is less than 4.0cm deep from the skin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with vasculitis or similar blood vessel inflammation.

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I have a history of blood clots in my veins or lungs.

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My treatment targets are near sensitive areas or large blood vessels.

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I have blood vessel abnormalities in my brain, face, head, neck, genitals, or internal organs.

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I cannot or do not want to receive HIFU treatment.

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My target blood vessels are wider than 6 mm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery.

Secondary study objectives

Short-term efficacy and technical feasibility of using the Sonablate High-Intensity Focused Ultrasound probe for ablating incompetent veins of the periphery