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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

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).

Key facts

Study ID

NCT01504308

Run by

Philips Healthcare

People needed

49

Starts

2012-05-01

Expected to finish

2016-03-01

Last updated by the study team

2017-04-05

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• Total planned ablation volume of all fibroids should not exceed 250 ml and
• No more than 5 fibroids should be planned for ablation and
• Dominant fibroid (diameter) is greater than or equal to 3 cm and
• 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

You may not qualify if…

• 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-month Lupron dose or equivalent: less than 1 month prior to MBL measurement or
• 3-month Lupron dose or equivalent: less than 3 months prior to MBL measurement or
• Depo Provera or equivalent: less than 6 months prior to MBL measurement

Where it is running

• University of Chicago — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Oregon Science and Health University — Portland, Oregon, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• St. Luke's Episcopal Hospital — Houston, Texas, United States
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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