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

M

Mirabilis Medica

Status

Completed

Conditions

Uterine Fibroids (Leiomyomas)

Treatments

Device: Mirabilis High-Intensity Focused Ultrasound Treatment System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01946178
No. 1006

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

73 participants in 1 patient group

Focused ultrasound treatment
Experimental group
Description:
Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.
Treatment:
Device: Mirabilis High-Intensity Focused Ultrasound Treatment System

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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