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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837161
First Posted: February 5, 2009
Last Update Posted: December 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Philips Healthcare
Results First Submitted: July 1, 2011  
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first High Intensity Focused Ultrasound (HIFU) treatment was on February 8, 2009 and the last patient was treated on March 5, 2010. 2 study sites enrolled patients, 2 from St. Lukes in Houston, TX and 9 from National Institutes of Health in Bethesda, MD.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened prior to treatment and the primary exclusion criteria was either uterine size per gestational age or fibroid size.

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.

Participant Flow:   Overall Study
    HIFU Treated
STARTED   11 
COMPLETED   9 
NOT COMPLETED   2 
refused hysterectomy                2 



  Baseline Characteristics
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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.
No text entered.

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
  Show All 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) ]

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

Measure Type Secondary
Measure Title HIFU Treatment Equals Location Per Hysterectomy
Measure Description Count the number of participants in which both of the following conditions are satisfied: the fibroid treated area as shown on MRI images during treatment is the same as displayed on fibroids from histology slices after hysterectomy, and no unintended lesions are visible in the uterus.
Time Frame Day 0, Hysterectomy  

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.
All participants who underwent hysterectomy following MR-HIFU treatment were included in this endpoint measure. Patients who refused hysterectomy were not included.

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.

Measured Values
   HIFU Treated 
Participants Analyzed 
[Units: Participants]
 9 
HIFU Treatment Equals Location Per Hysterectomy 
[Units: Participants]
 9 

No statistical analysis provided for HIFU Treatment Equals Location Per Hysterectomy



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)] ]

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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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