N/A N=73 Treatment

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

Uterine Fibroids (Leiomyomas)

Bottom Line

View on ClinicalTrials.gov: NCT01946178 ↗

Enrolled (actual)

Serious AEs

2.7%

Results posted

Mar 2016

Primary outcome: Primary: Evaluation of All Adverse Events Encountered — 0; 0.95 Adverse Device Effects / patient

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mirabilis High-Intensity Focused Ultrasound Treatment System (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Mirabilis Medica, Inc.
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluation of All Adverse Events Encountered	0; 0.95	—
SECONDARY HIFU-related Non-Perfused Volume (NPV)	20.1; 46.1	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01946178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.