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NCT06642051 · ClinicalTrials.gov registry record · NA
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
A NA study of Venous Leg Ulcers and Klippel-Trenaunay Syndrome, sponsored by Sonablate.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06642051: Active NA study of Venous Leg Ulcers and Klippel-Trenaunay Syndrome, sponsored by Sonablate.
NCT06642051 is a NA study of Venous Leg Ulcers and Klippel-Trenaunay Syndrome that is active but no longer recruiting, run by Sonablate. The registered enrollment target is 30 participants, below the 163-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06642051, a NA study of Venous Leg Ulcers and Klippel-Trenaunay Syndrome, is active but no longer recruiting, sponsored by Sonablate.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Safety as measured by the magnitude and frequency of adverse events from HIFU. This includes any burns, scalds, blistering and hyperemic changes on physical exam intraoperatively, at 6h, 24h, 1w, and 4 weeks post-operatively; worsening limb pain and swelling due to DVT diagnosed with Duplex Ultrasound within 4 weeks post-operatively; sensory nerve injury via formal neurological examination at 6h, 1w, and 4 weeks post-operatively.
Conditions Studied
Interventions
- DEVICE High Intensity focused ultrasound
Study Locations (1)
Connecticut
- The Vascular Care Group - Darien
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-09-11 |
| Est. Completion | 2028-02 |
| Phase | NA |
What the registry record for NCT06642051 still lists
NCT06642051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 163-participant average among 4 other Venous Leg Ulcers trials with a reported enrollment target (82% lower).
The record links to 6 conditions, with Venous Leg Ulcers appearing as the primary indexed condition, and to 1 intervention - of which High Intensity focused ultrasound is the first listed.
NCT06642051 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06642051 about?
NCT06642051 is a clinical study titled "Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery". 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 varic...
What is the current status of trial NCT06642051?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-09-11. Estimated completion is 2028-02.
What conditions does trial NCT06642051 study?
This clinical trial studies the following conditions: Venous Leg Ulcers, Klippel-Trenaunay Syndrome, CLOVES Syndrome, Blue Rubber Bleb Nevus Syndrome, Chronic Venous Insufficiency, CVI.
What interventions are being tested in trial NCT06642051?
The interventions under investigation include: High Intensity focused ultrasound (DEVICE).
Who is sponsoring clinical trial NCT06642051?
This trial is sponsored by Sonablate, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06642051 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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