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

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ClinicalTrials.gov Identifier: NCT01504308
Recruitment Status : Terminated (It was not possible to enroll patients into the study in a realistic timeframe.)
First Posted : January 5, 2012
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
Philips Healthcare

Tracking Information
First Submitted Date  ICMJE January 3, 2012
First Posted Date  ICMJE January 5, 2012
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
  • Alternative Interventional Treatment (AIT) [ Time Frame: 12 months after HIFU treatment ]
    AIT is scored dichotomously as follows: 0 = Failure. Failure occurs if an AIT for fibroid related symptoms is administered within 12 months of study treatment. 1 = Success. Success occurs if no AIT is administered for fibroid related symptoms within 12 months of study treatment. An AIT is defined as being one of the following: hysterectomy, myomectomy, uterine artery embolization, endometrial ablation and resection, or another MR-HIFU treatment (with the exception of a 're-treatment' as defined in the protocol, e.g. because of temporarily inaccessible fibroids).
  • Menstrual Blood Loss (MBL) [ Time Frame: at baseline and at 12 months following treatment ]
    Menstrual Blood Loss (MBL) scored dichotomously as follows: 0 = Failure. Failure occurs if the change from baseline in MBL measurement is < 50 % as measured with alkaline hematin test (AHT) method. 1 = Success. Success occurs if the change from baseline in MBL measurement is >= 50 %, or if the MBL is < 80 ml as measured with the AHT method.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
  • Return to Activity [ Time Frame: 72 hours ]
    Length for Return to Activity after HIFU treatment measured dichotomously: 0 = Failure. If subject takes longer than 72 hours to return to work or normal activity. 1 = Success. If subject returns to work or normal activity within 72 hours inclusive.
  • Symptom Severity Score (SSS) [ Time Frame: at baseline and at 12 months following treatment ]
    Symptom Severity Score (SSS) of Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QoL), assessed dichotomously at 12 months: 0 = Failure. Reduction of less than 10 points on SSS. 1 = Success. Reduction of at least 10 points on SSS.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids
Official Title  ICMJE Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Brief Summary 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).
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Uterine Fibroids
Intervention  ICMJE
  • Device: MR-HIFU treatment
    A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.
    Other Name: Philips Sonalleve MR-HIFU Uterine Fibroid Therapy
  • Device: Sham treatment
    A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.
    Other Name: pretend treatment with Philips Sonalleve MR-HIFU
Study Arms  ICMJE
  • Experimental: MR-HIFU treatment
    Patients receiving MR-HIFU treatment
    Intervention: Device: MR-HIFU treatment
  • Sham Comparator: Sham Treatment
    Patients receiving sham treatment
    Intervention: Device: Sham treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 27, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2012)
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Korea, Republic of,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01504308
Other Study ID Numbers  ICMJE 994045
G110008 ( Other Identifier: FDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Philips Healthcare
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Philips Healthcare
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John H Fischer II, MD St. Luke's Episcopal Hospital, Houston, Texas, United States
Principal Investigator: Robert K Zurawin, MD St. Luke's Episcopal Hospital, Houston, Texas, United States
Principal Investigator: Elizabeth David, MD Sunnybrook Health Sciences Center, Toronto, Ontario, Canada
Principal Investigator: Hyo Keun Lim, MD Samsung Medical Center, Seoul, Republic of Korea
Principal Investigator: Aytekin Oto, MD University of Chicago, Chicago, Illinois, United States
Principal Investigator: Amanda Yunker, D.O. Vanderbilt Medical Center
Principal Investigator: Peter Liu, M.D. University of Michigan
Principal Investigator: Rajiv Chopra, PhD University of Texas Southwestern Medical Center
PRS Account Philips Healthcare
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP