Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids (SOFIA)
Device: MR-HIFU treatment
Device: Sham treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Philips Pivotal Clinical Trial for MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids|
- Alternative Interventional Treatment (AIT) [ Time Frame: 12 months after HIFU treatment ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
- Return to Activity [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||May 2012|
|Study Completion Date:||March 2016|
|Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
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 Name: 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 Name: pretend treatment with Philips Sonalleve MR-HIFU
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504308
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|United States, Oregon|
|Oregon Science and Health University|
|Portland, Oregon, United States, 97239|
|United States, Tennessee|
|Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|St. Luke's Episcopal Hospital|
|Houston, Texas, United States, 77030|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada|
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|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|