Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642051
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Safety of the Sonablate HIFU System for the Ablation of Incompetent Veins of the Periphery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety of the Sonablate System for the High-Intensity Focused Ultrasound HIFU Ablation of Incompetent Veins of the Periphery
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIFIVE
Brief 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
Detailed Description:
The Sonablate High Intensity Focused Ultrasound HIFU system is a non-invasive technology that uses focused ultrasound waves to ablate targeted tissue within the body without ionizing radiation or surgical excision Through the precise delivery of ultrasonic waves HIFU rapidly elevates the temperature in the targeted tissue leading to the disruption of lipid membranes denaturation of proteins destruction of vascular endothelial cells and ultimately coagulative necrosis without damage to the overlying tissue This device is cleared by the FDA for the ablation of prostate tissue
This is a single arm single institution Phase one trial of 30 patients planned to last 18 months The primary endpoint is to assess the 30-day safety profile and technical feasibility of using the Sonablate high-intensity focused ultrasound HIFU system for ablating incompetent veins of the periphery This includes vascular malformations varicose veins and incompetent superficial veins
This is a single arm single institution Phase one trial of 30 patients planned to last 18 months The primary endpoint is to assess the 30-day safety profile and technical feasibility of using the Sonablate high-intensity focused ultrasound HIFU system for ablating incompetent veins of the periphery This includes vascular malformations varicose veins and incompetent superficial veins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None