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Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery

NCT06642051 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-19

No results posted yet for this study

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. 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.

Conditions

  • Chronic Venous Insufficiency, CVI
  • Venous Malformations
  • Venous Leg Ulcers
  • Klippel-Trenaunay Syndrome
  • CLOVES Syndrome
  • Blue Rubber Bleb Nevus Syndrome

Interventions

DEVICE

High Intensity focused ultrasound

Sonablate High Intensity Focused Ultrasound system to ablate incompetent veins of the periphery

Sponsors & Collaborators

  • Vascular Care CT, PLLC

    collaborator OTHER

  • Vascular Breakthroughs, LLC

    collaborator UNKNOWN

  • Sonablate

    lead INDUSTRY

Principal Investigators

  • Naiem Nassiri, MD, FSVS, RPVI · The Vascular Care Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2027-09-30
Completion
2028-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06642051 on ClinicalTrials.gov