Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner
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|ClinicalTrials.gov Identifier: NCT01064960|
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : December 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Uterine Leiomyomas||Device: Philips MR-guided HIFU system||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids in a 3T MRI Scanner|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
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.
- Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting. [ Time Frame: 30 days after treatment ]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 ]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 ]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 ]Mean Visual Analog Score (VAS) for pain 72 hours after treatment.
- Timeframe before returning to daily activities [ Time Frame: 72 hours after treatment ]Mean timeframe for the patient to return to normal activity after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064960
|Oslo University Hospital|
|Principal Investigator:||Erik Fosse, Professor||Oslo University Hospital|