Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

Lead Sponsor: Philips Healthcare

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

Uterine Fibroids are the most common benign tumors in pre- and peri-menopausal women. Fibroids occur in 20-50% of women over 30 years of age, and with increasing size can produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infertility. Symptomatic fibroids impact health and well-being of the female including lost work hours and reduced quality of life. Current medical treatments include invasive removal of the fibroid (hysterectomy, myomectomy), drug therapy, or treatments causing necrosis of the fibroid tissue such as ablation (freezing or heating) or embolization. It has been estimated that 600,000 hysterectomies are performed per year in the United States and more than half of the conducted hysterectomies are due to fibroids. For the relief of symptoms, women wishing to preserve the uterus may choose between invasive procedures of myomectomy, Uterine Artery Embolization (UAE), ablation or cryotherapy. The surgically invasive procedures require anesthesia, hospital stays, and long recovery periods. However, High Intensity Focused Ultrasound (HIFU) shows promising results in relieving fibroid symptoms. This study will confirm the safety and clinical effectiveness of Philips Sonalleve MR-HIFU Fibroid Therapy system for ablating symptomatic fibroids.

• Uterine Fibroids

Intervention Type: Device

Intervention Name: MR-HIFU treatment

Description: A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.

Arm Group Label: MR-HIFU treatment

Other Name: Philips Sonalleve MR-HIFU Uterine Fibroid Therapy

Intervention Type: Device

Intervention Name: Sham treatment

Description: A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.

Arm Group Label: Sham Treatment

Other Name: pretend treatment with Philips Sonalleve MR-HIFU

Criteria:

Inclusion Criteria: - Women, age between 18 and 50 years - Ethnicity has a match with the intended profile for the site - Weight < 140kg or 310lbs - Pre- or peri-menopausal as indicated by clinical evaluation or Follicle Stimulating Hormone (FSH) level < 40 IU/L - Willing and able to attend all study visits - Willing and able to complete Menstrual Blood Loss (MBL) assessment with Alkaline Hematin (AH) method - Willing and able to use reliable contraception methods - Uterine size < 24 weeks - Cervical cell assessment by Pap smear: Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue - MR-HIFU device accessibility to fibroids such that at least 50% of the total fibroid volume can be treated. - Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol): 1. Total planned ablation volume of all fibroids should not exceed 250 ml and 2. No more than 5 fibroids should be planned for ablation and 3. Dominant fibroid (diameter) is greater than or equal to 3 cm and 4. Completely non-enhancing fibroids should not be treated as the identification of treated volume becomes ambiguous - Patient's self-assessment indicates that she has had episodes of heavy menstrual bleeding in the past 6 months. - Menstrual Blood Loss (MBL) ≥150 ml and ≤ 500 ml Exclusion Criteria: - Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) - Desire for future pregnancy - Significant systemic disease even if controlled - Positive pregnancy test - Hematocrit < 25% - Extensive scarring along anterior lower abdominal wall (>50% of area) - Surgical clips in the potential path of the HIFU beam - MRI contraindicated - MRI contrast agent contraindicated (including renal insufficiency) - Calcifications around or throughout uterine tissues that may affect treatment - Communication barrier - Highly perfused or brighter than myometrium in T2-weighted MRI (according to the T2 contrast obtained using the Philips MR-HIFU MR protocol) fibroids - Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible) - Menses lasting > 7 days or intermenstrual bleeding (patient can be included if there is endometrial biopsy within 6 months to exclude malignancy) - Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below: 1. 1-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or 2. 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or 3. Depo Provera or equivalent: less than 6 months prior to MBL measurement

Gender: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: No

Canada

Korea, Republic of

United States

April 2017

Type: Sponsor

• uterine fibroids
• uterine leiomyomas
• magnetic resonance imaging
• focused ultrasound

• Leiomyoma
• Myofibroma

Label: MR-HIFU treatment

Type: Experimental

Description: Patients receiving MR-HIFU treatment

Label: Sham Treatment

Type: Sham Comparator

Description: Patients receiving sham treatment

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)