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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mirabilis Medica, Inc.
Sponsor:
Information provided by (Responsible Party):
Mirabilis Medica, Inc.
ClinicalTrials.gov Identifier:
NCT01946178
First received: September 16, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Uterine Fibroids (Leiomyomas)
Device: Mirabilis High-Intensity Focused Ultrasound Treatment System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia

Resource links provided by NLM:


Further study details as provided by Mirabilis Medica, Inc.:

Primary Outcome Measures:
  • Evaluation of all adverse events encountered [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    Safety of the intervention will be determined by evaluating the incidence and severity of adverse events and adverse device effects.


Secondary Outcome Measures:
  • Observation of tissue response via pathological assessment of fibroid specimens following hysterectomy and/or post-treatment magnetic resonance imaging (MRI) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Preliminary efficacy of the intervention will be determined by evaluating the dimensions and position of nonviable tissue observed in each fibroid specimen via pathological processing following hysterectomy and/or by assessing the non-perfused volume (NPV) observed on post-treatment contrast-enhanced MRI.


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Focused ultrasound treatment
Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.
Device: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Age 18-55 years
  • Scheduled to undergo abdominal hysterectomy due to benign pathology including uterine fibroids
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946178

Contacts
Contact: Michael Lau, M.D. 425-486-8230 ext 203 mlau@mirabilismedica.com

Locations
Mexico
Hospital Torre Medica Recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 06030
Principal Investigator: Juan M. Aguilar Aguirre, M.D.         
Hospital Universitario, Universidad Autonoma de Nuevo Leon Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Principal Investigator: Jose G. Garza Leal, M.D.         
Sponsors and Collaborators
Mirabilis Medica, Inc.
  More Information

No publications provided

Responsible Party: Mirabilis Medica, Inc.
ClinicalTrials.gov Identifier: NCT01946178     History of Changes
Other Study ID Numbers: No. 1006
Study First Received: September 16, 2013
Last Updated: March 24, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Mirabilis Medica, Inc.:
Uterine Fibroids
Leiomyomas
High-Intensity Focused Ultrasound Ablation
Ultrasonography

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on November 24, 2014