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

April 3, 2017 updated by: Philips Healthcare

Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Samsung Medical Center
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Science and Health University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Medical Center
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MR-HIFU treatment
Patients receiving MR-HIFU treatment
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 Names:
  • Philips Sonalleve MR-HIFU Uterine Fibroid Therapy
Sham Comparator: Sham Treatment
Patients receiving sham treatment
Device: Sham treatment
A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.
Other Names:
  • pretend treatment with Philips Sonalleve MR-HIFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months after HIFU treatment
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.
at baseline and at 12 months following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours
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.
at baseline and at 12 months following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Healthcare

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 5, 2012

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 994045
  • G110008 (Other Identifier: FDA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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