Therapeutic MRI-HIFU Ablation of Uterine Fibroids in a 3T MRI Scanner
|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|
|Primary Completion Date :||July 2011|
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064960
|Oslo University Hospital|
|Principal Investigator:||Erik Fosse, Professor||Oslo University Hospital|