Directed Ablation of Uterine Fibroids Using a Noninvasive Approach

NCT03219385 | Unknown FDA Device

• 1 other identifier: MMI 2001
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Uterine Leiomyoma

Keywords

uterine leiomyoma; uterine fibroid; uterine myoma; abnormal menstrual bleeding; heavy menstrual bleeding; menorrhagia; high-intensity focused ultrasound; ultrasound imaging

Outcome Measures

Primary Outcomes (3)

• Change in menstrual bleeding as measured by the Menstrual Pictogram (MP) score

  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.

  At 12 months after treatment

• Rate of reintervention

  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.

  At 12 months after treatment

• Adverse event reports

  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.

  Within 12 months after treatment

Secondary Outcomes (5)

• Change in Uterine Fibroid Symptom - Quality of Life (UFS-QOL) survey score

  At 12 months after treatment

• Percentage of patients achieving pre-specified reductions in Menstrual Pictogram (MP) score

  At 12 months after treatment

• Change in treated fibroid volume as assessed by gadolinium-enhanced MRI

  At 6 months after treatment

• Presence of newly-formed non-perfused volumes (NPV) in the targeted tissue

  Within 72 hours after treatment

• Adverse event reports

  Within 24 months after treatment and within 36 months after treatment

Study Arms (1)

Treatment with the Mirabilis System

EXPERIMENTAL

Device: Mirabilis System

Interventions

Mirabilis System DEVICE

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.

Treatment with the Mirabilis System

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients between the ages of 18 to 50 years of age.
• Patients must have 1-3 treatable fibroids with at least one distorting the endometrial cavity.
• Patients must have at least 1 treatable fibroid or cluster of fibroids that measures between 2 cm to 7 cm in diameter with diagnostic ultrasound.
• Patients must have primary complaint of prolonged and/or heavy menstrual bleeding.
• Patients must be in generally good health and seeking relief of fibroid related symptoms.
• Patients must have a normal Pap smear within 36 months of enrollment, including an endometrial biopsy, if clinically indicated.
• Patients must be willing to adhere to the study schedule.
• Patients must have a baseline Menstrual Pictogram (MP) score between 150 mL and 500 mL.
• Patients must agree to abstain from having other treatments or therapies for fibroids, including procedures (i.e. uterine artery embolization, hysterectomy, radiofrequency ablation of fibroids, etc.) or medications (i.e. hormone therapy for treatment of fibroids; prescription or over the counter medications, including standard, homeopathic, or naturopathic medications, for the treatment of fibroids; dietary supplements taken for the treatment of fibroids, etc.). Exceptions include the use of analgesics or other pain control medications.
• Patients must have regular cyclical menstrual periods.
• Patients must be willing to maintain use of their current form of birth control during screening and for 12 months after treatment.
• Patients must be willing and able to consent to participate in the study.

You may not qualify if:

• Patients who are pregnant, suspected to be pregnant, or wish to become pregnant.
• Patients unable or unwilling to use only the sanitary products provided by Sponsor during their participation in the study.
• Patients with fibroids that are deeper than the maximal treatment depth of the Mirabilis System.
• Patients with fibroids that have certain MRI characteristics including:
• A hyper-intense appearance on T2-weighted MRI where the fibroid tissue appears brighter than surrounding myometrium
• Features consistent with high perfusion, low perfusion, non-perfusion, infarct, or ischemia on gadolinium-enhanced MRI
• Features consistent with extensive degeneration
• Fibroids are not quantifiable on MRI
• Any endometrial polyp 1 cm or larger
• Type 0 fibroids (pedunculated intracavitary)
• Patients with known endometrial hyperplasia.
• Patients planning or seeking additional therapies for the treatment of fibroids and/or abnormal uterine bleeding.
• Patients with other pelvic masses of unknown etiology.
• Patients who are postmenopausal.
• Patients with an active diagnosis of cancer of any type.

Sponsors & Collaborators

• Mirabilis Medica, Inc.: lead

Related Publications (8)

• 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: 28109895 BACKGROUND

• 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).

  BACKGROUND

• 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).

  BACKGROUND

• 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).

  BACKGROUND

• 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).

  BACKGROUND

• Magnay JL, Nevatte TM, O'Brien S, Gerlinger C, Seitz C. Validation of a new menstrual pictogram (superabsorbent polymer-c version) for use with ultraslim towels that contain superabsorbent polymers. Fertil Steril. 2014 Feb;101(2):515-22. doi: 10.1016/j.fertnstert.2013.10.051. Epub 2013 Dec 12.

  PMID: 24331833 BACKGROUND

• Magnay JL, Nevatte TM, Seitz C, O'Brien S. A new menstrual pictogram for use with feminine products that contain superabsorbent polymers. Fertil Steril. 2013 Dec;100(6):1715-21.e1-4. doi: 10.1016/j.fertnstert.2013.08.028. Epub 2013 Sep 11.

  PMID: 24034941 BACKGROUND

• Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. doi: 10.1016/s0029-7844(01)01702-1.

  PMID: 11814511 BACKGROUND

MeSH Terms

Conditions

Myofibroma; Leiomyoma; Menorrhagia

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neoplasms, Muscle Tissue; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Michael Lau, M.D.

  Mirabilis Medica, Inc.

  STUDY DIRECTOR

Central Study Contacts

Patrick Martin

CONTACT

425-486-8230; patrick@mirabilismed.com

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: July 13, 2017
• First Posted: July 17, 2017
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2022
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share