NCT03219385

Directed Ablation of Uterine Fibroids Using a Noninvasive Approach

Directed Ablation of Uterine Fibroids Using a Noninvasive Approach (DIANA)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Mirabilis Medica, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis System for treating uterine fibroids in women who are seeking relief from fibroid-related abnormal uterine bleeding but want to avoid hysterectomies or other surgical procedures. The Mirabilis System is an investigational device that delivers high-intensity focused ultrasound (HIFU) to the uterus using integrated ultrasound imaging guidance to offer noninvasive treatment for uterine fibroids. With the Mirabilis System, HIFU is applied noninvasively through the skin using an applicator that is placed against the abdomen. No incisions or surgical procedures are required. During this study, eligible patients will have one or more fibroids treated with the Mirabilis System and will then remain in the study for a total of 36 months after treatment to monitor the occurrence of adverse events. Primary endpoints will be assessed at 12 months after treatment, while secondary endpoints will be assessed at variable times ranging from immediately after treatment up to 36 months after treatment.

Conditions

• Uterine Leiomyoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-09-01
• Completion: 2022-09-01
• First posted: 2017-07-17
• Last updated: 2018-03-21

Regulatory

• FDA-regulated device study