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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mirabilis Medica, Inc.
ClinicalTrials.gov Identifier:
NCT01946178
First received: September 16, 2013
Last updated: February 24, 2016
Last verified: February 2016
  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 or who are seeking relief from fibroid-related symptoms.

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: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment). ] [ Designated as safety issue: Yes ]
    Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.


Secondary Outcome Measures:
  • HIFU-related Non-Perfused Volume (NPV) [ Time Frame: The NPV was measured between 0 and 7 days post-treatment. ] [ Designated as safety issue: No ]
    Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.


Enrollment: 73
Study Start Date: January 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (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   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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

Locations
Mexico
Hospital Torre Medica
Ciudad de Mexico, Distrito Federal, Mexico, 06030
Hospital Universitario, Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Mirabilis Medica, Inc.
Investigators
Study Director: Michael Lau, M.D. Mirabilis Medica, Inc.
  More Information

Publications:
Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Martin PM, and Lau MPH. Refinement of the Shell Ablation Technique for Rapid In-Office Treatment of Uterine Fibroids under Ultrasound Imaging Guidance using the Mirabilis Transabdominal HIFU System. 15th International Symposium on Therapeutic Ultrasound Program and Abstracts: 156 (2015).
Garza Leal JG, Hernandez Leon I, Castillo Saenz L, Aguilar Aguirre JM, Islas Lagos JJ, Parsons JE, Darlington GP, and Lau MPH. In-Office Rapid Volumetric Ablation of Uterine Fibroids under Ultrasound Imaging Guidance: Preclinical and Early Clinical Experience with the Mirabilis Transabdominal HIFU Treatment System. 14th International Symposium on Therapeutic Ultrasound Program and Abstracts: 43 (2014).
Lau M, Aguilar Aguirre JM, Islas Lagos JJ, and Garza Leal JG. Office Based High-Speed Ultrasound Image Guided HIFU (High Intensity Focused Ultrasound) Ablation of Uterine Fibroids. Gynecol. Surg. 11 (Suppl. 1): 149-150 (2014).

Responsible Party: Mirabilis Medica, Inc.
ClinicalTrials.gov Identifier: NCT01946178     History of Changes
Other Study ID Numbers: No. 1006 
Study First Received: September 16, 2013
Results First Received: February 24, 2016
Last Updated: February 24, 2016
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
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on December 09, 2016