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Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT00837161
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : November 28, 2011
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Uterine Fibroids
Uterine Leiomyomata
Intervention: Device: Philips MR guided HIFU system

  Participant Flow


  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
HIFU Treated Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.

Baseline Measures
   HIFU Treated 
Overall Participants Analyzed 
[Units: Participants]
 		 11 
Age 
[Units: Participants]
 		 
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 46.7  (5.7) 
Gender 
[Units: Participants]
 		 
Female   11 
Male   0 
Region of Enrollment 
[Units: Participants]
 		 
United States   11 


  Outcome Measures

1.  Primary:   Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids   [ Time Frame: end of follow-up (date of hysterectomy, at latest day 30 after treatment) ]
  Show Outcome Measure 1

2.  Secondary:   HIFU Treatment Equals Location Per Hysterectomy   [ Time Frame: Day 0, Hysterectomy ]
  Show Outcome Measure 2

3.  Secondary:   Length of Time to Return to Normal Activities   [ Time Frame: end of follow-up (date of hysterectomy, at latest day 30 after treatment)] ]
  Show Outcome Measure 3

4.  Secondary:   Numerical Range Scale (NRS) of Pain Level   [ Time Frame: Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Discomfort Level   [ Time Frame: Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks ]
  Show Outcome Measure 5


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information