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

Study acronym: HIFIVE
StatusActive, Not Recruiting
PhaseNot applicable
SponsorSonablate
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Sep 2025 to Sep 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Feb 2026 to Feb 2028
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sonablate
2 trials monitored
See all monitored trials
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.
Trial Details
NCT Number NCT06642051
Lead Sponsor Sonablate
Collaborators: Vascular Care CT, PLLC, Vascular Breakthroughs, LLC
Conditions
(from sponsor)		 Chronic Venous Insufficiency, CVI, Venous Malformations, Venous Leg Ulcers, Klippel-Trenaunay Syndrome, CLOVES Syndrome, Blue Rubber Bleb Nevus Syndrome
Related terms Blindness, Cortical, Blue rubber bleb nevus syndrome, Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi, Klippel-Trenaunay-Weber Syndrome
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov