Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-05-31

Brief Summary

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The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.

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Detailed Description

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Conditions

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Uterine Fibroids (Leiomyomas)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Focused ultrasound treatment

Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.

Group Type EXPERIMENTAL

Mirabilis High-Intensity Focused Ultrasound Treatment System

Intervention Type DEVICE

The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.

Interventions

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Mirabilis High-Intensity Focused Ultrasound Treatment System

The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female
* Age 18-55 years
* Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology
* Patients able and willing to provide informed consent

Exclusion Criteria

* Visible scar within the HIFU beam path that cannot be avoided
* Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall
* Currently pregnant or desire to become pregnant in the future
* Pelvic malignancy
* Pelvic congenital malformation
* Acute pelvic infection
* Otherwise determined by a physician to be inappropriate for the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No