Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner
This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary 3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner|
- Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting. [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]Number of adverse events reported in the study divided by the total number of treated subjects.
- Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]Mean absolute change in the Symptom Severity Score (SSS) of the uterine Fibroid Symptoms Quality of Life questionnaire from baseline to 30 days after treatment.
- Change in Quality of Life Scores [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]Mean absolute score change in the Quality of Life questionnaire from baseline to 30 days after treatment.
- Pain score [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: No ]Mean Visual Analog Score (VAS) for pain 72 hours after treatment.
- Timeframe before returning to daily activities [ Time Frame: 72 hours after treatment ] [ Designated as safety issue: No ]Mean timeframe for the patient to return to normal activity after treatment.
|Study Start Date:||January 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Treated leiomyomas
Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure are treated with the Philips MR-guided HIFU system. Patients must have completed child bearing prior to enrolling in this study.
Device: Philips MR-guided HIFU system
HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.
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