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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focused ultrasound treatment | Experimental | Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabilis High-Intensity Focused Ultrasound Treatment System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The NPV was measured between 0 and 7 days post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lau, M.D. | Mirabilis Medica, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Torre Medica | Mexico City | Mexico City | 06030 | Mexico | ||
| Hospital Universitario, Universidad Autonoma de Nuevo Leon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28109895 | Result | 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. | |
| 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. 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). |
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Patients were screened prior to treatment for eligibility criteria including size, location, and tissue characteristics of their uterine fibroid(s). Those patients meeting the established eligibility criteria were then scheduled for treatment.
All patients underwent transabdominal uterine fibroid treatment with the Mirabilis High-Intensity Focused Ultrasound Treatment System between January 8, 2011 and November 21, 2014 at two clinical sites in Mexico. The study was completed on May 20, 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Treated Patients | All patients who underwent treatment with the device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Monterrey |
| Nuevo León |
| 64460 |
| Mexico |
| 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). |
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| NOT COMPLETED |
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Baseline characteristics are reported for the entire study population (all treated patients).
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treated Patients | All patients who underwent treatment with the device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All Adverse Device Effects are reported for the entire study population (all treated patients). | Posted | Mean | Full Range | Adverse Device Effects / patient | Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment). |
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| Secondary | 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. | HIFU-related Non-Perfused Volumes (NPVs) are reported for all treated patients in whom they were observed following treatment. NPV outcomes are stratified between two cohorts: an early Development Cohort and a final Validation Cohort. | Posted | Mean | Full Range | cubic centimeters (cc) | The NPV was measured between 0 and 7 days post-treatment. |
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| Post-Hoc | Total Time Required to Deliver Treatment | The total treatment time was measured for each patient from the beginning of HIFU energy emission until HIFU energy emission stopped. | Total treatment times are reported for all treated patients. Total treatment times are stratified between two cohorts: an early Development Cohort and a final Validation Cohort. | Posted | Mean | Full Range | minutes | The total treatment time was measured on the day of treatment. |
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Monitoring for Adverse Events occurred from January 8, 2011 until May 20, 2015. Adverse Events were monitored until each patient's exit from the study, which was up to 6 months following treatment.
All Adverse Events are reported for all patients receiving treatment, including those events not related to treatment. Adverse Events were reported spontaneously by patients, observed by the investigator or other personnel, and/or elicited during patient queries at regular follow-up intervals. Descriptions were mapped to standardized terms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Treated Patients | All patients who underwent treatment with the device | 2 | 73 | 53 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea unrelated to treatment | General disorders | Systematic Assessment | related to concurrent E. coli infection |
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| Depressed respiration with apnea unrelated to treatment | General disorders | Systematic Assessment | related to analgesic administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramping pain during HIFU | General disorders | Systematic Assessment |
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| Abdominal cramping pain post HIFU | General disorders | Systematic Assessment |
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| Vaginal bleeding | General disorders | Systematic Assessment |
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| Nausea with vomiting unrelated to treatment | General disorders | Systematic Assessment |
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| Headache unrelated to treatment | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Mirabilis Medica, Inc. | 425-486-8230 | patrick@mirabilismedica.com |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Participants |
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