Clinical trial NCT01946178: 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
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids (Leiomyomas)
Keywords: Uterine Fibroids
Leiomyomas
High-Intensity Focused Ultrasound Ablation
Ultrasonography
Lead sponsor: Mirabilis Medica, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-19
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluation of All Adverse Events Encountered
timeFrame: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).
Secondary outcomes:
measure: HIFU-related Non-Perfused Volume (NPV)
timeFrame: The NPV was measured between 0 and 7 days post-treatment.
Other outcomes:
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Hospital Torre Medica
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario, Universidad Autonoma de Nuevo Leon
state: Nuevo Leon
Study officials:
affiliation: Mirabilis Medica, Inc.
name: Michael Lau, M.D.
role: STUDY_DIRECTOR
References:
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.
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).
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).
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).
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).