NCT01946178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 25, 2016

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

4.3 years

First QC Date

September 16, 2013

Results QC Date

February 24, 2016

Last Update Submit

April 28, 2017

Conditions

Uterine Fibroids (Leiomyomas)

Keywords

Uterine FibroidsLeiomyomasHigh-Intensity Focused Ultrasound AblationUltrasonography

Outcome Measures

Primary Outcomes (1)

  • 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.

    Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).

Secondary Outcomes (1)

  • HIFU-related Non-Perfused Volume (NPV)

    The NPV was measured between 0 and 7 days post-treatment.

Study Arms (1)

Focused ultrasound treatment

EXPERIMENTAL

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

Interventions

Mirabilis High-Intensity Focused Ultrasound Treatment SystemDEVICE

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.

Focused ultrasound treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Torre Medica

Mexico City, Mexico City, 06030, Mexico

Location

Hospital Universitario, Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (5)

  • 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.

    PMID: 28109895RESULT

  • 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).

    RESULT

  • 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).

    RESULT

  • 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).

    RESULT

  • 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).

    RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Results Point of Contact

Title
Director of Clinical Affairs
Organization
Mirabilis Medica, Inc.
patrick@mirabilismedica.com
425-486-8230

Study Officials

  • Michael Lau, M.D.

    Mirabilis Medica, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 19, 2013

Study Start

January 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 30, 2017

Results First Posted

March 25, 2016

Record last verified: 2017-04

Locations

ME(2)