Directed Ablation of Uterine Fibroids Using a Noninvasive Approach

NAUnknownINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 30, 2018

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2022

Conditions
Uterine Leiomyoma
Interventions
DEVICE

Mirabilis System

The intervention is a transabdominal treatment performed with the Mirabilis System, during which high-intensity focused ultrasound (HIFU) is applied noninvasively through the skin using an applicator placed against the abdomen. One or more appropriately selected uterine fibroids will be treated with HIFU using integrated ultrasound imaging to guide the treatment. HIFU causes localized heating and mechanical effects to develop in the targeted fibroid(s) that result in therapeutic destruction of the fibroid tissue, leading to improvement in related symptoms.

Sponsors
All Listed Sponsors
lead

Mirabilis Medica, Inc.

INDUSTRY