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

Philips

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Uterine Fibroids

Treatments

Device: Sham treatment

Device: MR-HIFU treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT01504308

994045

G110008 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

49 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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