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

Primary Purpose

Uterine Fibroids (Leiomyomas)

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Mirabilis High-Intensity Focused Ultrasound Treatment System
Sponsored by
Mirabilis Medica, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids (Leiomyomas) focused on measuring Uterine Fibroids, Leiomyomas, High-Intensity Focused Ultrasound Ablation, Ultrasonography

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Hospital Torre Medica
  • Hospital Universitario, Universidad Autonoma de Nuevo Leon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focused ultrasound treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of All Adverse Events Encountered
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)
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.

Full Information

First Posted
September 16, 2013
Last Updated
April 28, 2017
Sponsor
Mirabilis Medica, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01946178
Brief Title
Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
Official Title
Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirabilis Medica, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids (Leiomyomas)
Keywords
Uterine Fibroids, Leiomyomas, High-Intensity Focused Ultrasound Ablation, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focused ultrasound treatment
Arm Type
Experimental
Arm Description
Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.
Intervention Type
Device
Intervention Name(s)
Mirabilis High-Intensity Focused Ultrasound Treatment System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of All Adverse Events Encountered
Description
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.
Time Frame
Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).
Secondary Outcome Measure Information:
Title
HIFU-related Non-Perfused Volume (NPV)
Description
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.
Time Frame
The NPV was measured between 0 and 7 days post-treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lau, M.D.
Organizational Affiliation
Mirabilis Medica, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Torre Medica
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06030
Country
Mexico
Facility Name
Hospital Universitario, Universidad Autonoma de Nuevo Leon
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
28109895
Citation
Parsons JE, Lau MPH, Martin PJ, Islas Lagos JJ, Aguilar Aguirre JM, Garza Leal JG. Pilot Study of the Mirabilis System Prototype for Rapid Noninvasive Uterine Myoma Treatment Using an Ultrasound-Guided Volumetric Shell Ablation Technique. J Minim Invasive Gynecol. 2017 May-Jun;24(4):579-591. doi: 10.1016/j.jmig.2017.01.010. Epub 2017 Jan 18.
Results Reference
result
Citation
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. Proceedings of the 14th International Symposium on Therapeutic Ultrasound. AIP Conference Proceedings 1821: 020001 (2017).
Results Reference
result
Citation
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).
Results Reference
result
Citation
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).
Results Reference
result
Citation
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).
Results Reference
result

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

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