A Phase 2/3 interventional study of MR-HIFU treatment and Sham treatment in Uterine Fibroids, sponsored by Philips Healthcare. Terminated at 9 sites in 3 countries. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by Philips Healthcare · Phase 2/3, Interventional, and Treatment
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).
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 49 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Philips Healthcare is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fibroids selected for treatment meeting the following criteria (further extrapolated in the protocol):
Exclusion Criteria:
Patient is currently on hormonal medication for fibroids or has a hormonal medication history as described below:
Patients receiving MR-HIFU treatment
Device: MR-HIFU treatment
Patients receiving sham treatment
Device: Sham treatment
A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.
Also known as: Philips Sonalleve MR-HIFU Uterine Fibroid Therapy
A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.
Also known as: pretend treatment with Philips Sonalleve MR-HIFU
Alternative Interventional Treatment (AIT)
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).
Time frame: 12 months after HIFU treatment
Menstrual Blood Loss (MBL)
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.
Time frame: at baseline and at 12 months following treatment
Return to Activity
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.
Time frame: 72 hours
Symptom Severity Score (SSS)
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.
Time frame: at baseline and at 12 months following treatment
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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