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The intervention is a transabdominal treatment performed with the Mirabilis System, during which high-intensity focused ultrasound (HIFU) is applied noninvasively through the skin using an applicator placed against the abdomen. One or more appropriately selected uterine fibroids will be treated with HIFU using integrated ultrasound imaging to guide the treatment. HIFU causes localized heating and mechanical effects to develop in the targeted fibroid(s) that result in therapeutic destruction of the fibroid tissue, leading to improvement in related symptoms.

Mirabilis System

Patrick Martin

Michael Lau, M.D.

The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis System for treating uterine fibroids in women who are seeking relief from fibroid-related abnormal uterine bleeding but want to avoid hysterectomies or other surgical procedures. The Mirabilis System is an investigational device that delivers high-intensity focused ultrasound (HIFU) to the uterus using integrated ultrasound imaging guidance to offer noninvasive treatment for uterine fibroids. With the Mirabilis System, HIFU is applied noninvasively through the skin using an applicator that is placed against the abdomen. No incisions or surgical procedures are required. During this study, eligible patients will have one or more fibroids treated with the Mirabilis System and will then remain in the study for a total of 36 months after treatment to monitor the occurrence of adverse events. Primary endpoints will be assessed at 12 months after treatment, while secondary endpoints will be assessed at variable times ranging from immediately after treatment up to 36 months after treatment.

Directed Ablation of Uterine Fibroids Using a Noninvasive Approach

Directed Ablation of Uterine Fibroids Using a Noninvasive Approach (DIANA)

The Menstrual Pictogram (MP) is a validated pictorial instrument for measuring menstrual bleeding using modern superabsorbent sanitary products \[6,7\]. The MP score will be measured at 12 months after treatment and compared to the patient's baseline score to assess whether an improvement occurred. Success is defined for an individual patient as a ≥ 50% reduction in MP score from baseline or a final MP score ≤ 80 mL.

For the purposes of this study, reintervention refers to a procedure for the treatment of abnormal uterine bleeding related to fibroids other than a HIFU treatment using the Mirabilis System. A procedure is defined to include uterine artery embolization, endometrial ablation, radiofrequency ablation, cryotherapy, myomectomy, and hysterectomy. An additional treatment with the Mirabilis System as allowed by the protocol is not considered a reintervention. The rate of reintervention is defined as the percentage of patients who complete treatment with the Mirabilis System and subsequently undergo a different procedure for the treatment of abnormal uterine bleeding related to fibroids within 12 months after treatment. Success is defined for an individual patient as an absence of reintervention within this period.

The primary safety analysis will be performed on all patients receiving any HIFU treatment and will consist of a standardized assessment of all adverse events reported from the time that the patient's treatment starts until 12 months after treatment. The totality of safety information obtained from adverse event reports over this timeframe will be used to characterize the primary safety profile of the Mirabilis System via descriptive summaries.

The Uterine Fibroid Symptom - Quality of Life (UFS-QOL) survey is a validated and fibroid-specific assessment tool for measuring fibroid-related symptoms and their impact on the patient's quality of life \[8\]. The UFS-QOL survey score will be measured at 12 months after treatment and compared to the patient's baseline score to assess whether an improvement occurred. Because this is a secondary endpoint, the change in UFS-QOL survey score will be reported for informational purposes only, and there is no threshold for defining success in an individual patient.

The percentage of all patients completing treatment with the Mirabilis System who achieve pre-specified reductions in Menstrual Pictogram (MP) score at 12 months after treatment will be determined. These pre-specified reductions are: (1) percentage of patients achieving ≥ 22% reduction in MP score, (2) percentage of patients achieving ≥ 30% reduction in MP score, and (3) percentage of patients achieving ≥ 40% reduction in MP score. Because this is a secondary endpoint, these percentages of patients will be reported for informational purposes only, and there is no threshold for defining success for these percentages.

The volume of each treated fibroid will be measured via gadolinium-enhanced MRI at 6 months after treatment and compared to its baseline volume also measured via gadolinium-enhanced MRI to assess whether fibroid shrinkage occurred. Because this is a secondary endpoint, the change in treated fibroid volume will be reported for informational purposes only, and there is no threshold for defining success in an individual patient.

The non-perfused volume (NPV) is the volume of tissue that no longer has blood flow as a result of treatment and is used as a marker of acute treatment effectiveness. The presence or absence of a newly-formed NPV (i.e., one that was not present prior to treatment) will be assessed via gadolinium-enhanced MRI within 72 hours after treatment. Because this is a secondary endpoint, the presence or absence of newly-formed NPVs will be reported for informational purposes only, and there is no NPV size threshold for defining success in an individual patient.

The secondary safety analysis will be performed analogously to the primary safety analysis on all adverse events reported within 24 months and within 36 months after treatment. The totality of safety information obtained from adverse event reports over these timeframes will be used to characterize the longer-term safety profile of the Mirabilis System via descriptive summaries.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Directed Ablation of Uterine Fibroids Using a Noninvasive Approach	NCT03219385	Uterine Leiomyo...	Mirabilis Syste...	18 Years - 50 Years	Mirabilis Medica, Inc.
Directed Ablation of Uterine Fibroids Using a Noninvasive Approach	NCT03219385	Uterine Leiomyo...	Mirabilis Syste...	18 Years - 50 Years	Mirabilis Medica, Inc.

Spots Global Cancer Trial Database for abnormal menstrual bleeding