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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT00837161
First received: February 4, 2009
Last updated: November 30, 2012
Last verified: November 2012
Results First Received: July 1, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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
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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) ]

Measure Type Primary
Measure Title Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids
Measure Description The number of treatment-related Adverse Events (AE) reported during the study, divided by the total number of treated subjects. This corresponds to the mean number of treatment-related Adverse Events per subject. Relatedness of an AE to the treatment was judged case-by-case by the investigator.
Time Frame end of follow-up (date of hysterectomy, at latest day 30 after treatment)  
Safety Issue Yes  

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.
Safety was assessed per protocol; all 11 participants were evaluated for adverse events after HIFU treatment.

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  
Number of Participants Analyzed  
[units: participants]
  11  
Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids  
[units: treatment-related AE/patient]
Mean ( Full Range )
  1.3  
  ( 0 to 3 )  

No statistical analysis provided for Treatment-related Adverse Events (AE) Per Subject Resulting From HIFU Treatment of the Uterine Fibroids



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

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  
Safety Issue Yes  

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  
Number of 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)] ]

Measure Type Secondary
Measure Title Length of Time to Return to Normal Activities
Measure Description Length of time to return to normal activity measured in number of days from HIFU treatment. Assessed by patient interviews during follow-up.
Time Frame end of follow-up (date of hysterectomy, at latest day 30 after treatment)]  
Safety Issue No  

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.
per protocol

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  
Number of Participants Analyzed  
[units: participants]
  11  
Length of Time to Return to Normal Activities  
[units: days]
Mean ( Full Range )
  1.4  
  ( 1 to 3 )  

No statistical analysis provided for Length of Time to Return to Normal Activities



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 ]

Measure Type Secondary
Measure Title Numerical Range Scale (NRS) of Pain Level
Measure Description Pain Scores obtained by patient self-assessment on a 0-10 scale, with 0 corresponding to no pain and 10 corresponding to maximum pain.
Time Frame Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks  
Safety Issue No  

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.

Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.

Analysed subject numbers were:

from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;


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  
Number of Participants Analyzed  
[units: participants]
  11  
Numerical Range Scale (NRS) of Pain Level  
[units: units on a scale]
Mean ( Full Range )
 
Treatment Day: Baseline     1.3  
  ( 0 to 5 )  
Treatment Day: Recovery     2.6  
  ( 0 to 6 )  
Treatment Day: Discharge     1.4  
  ( 0 to 6 )  
24 hours after treatment     2.4  
  ( 0 to 6 )  
48 hours after treatment     1.5  
  ( 0 to 5 )  
72 hours after treatment     1.3  
  ( 0 to 4 )  
1 week after treatment     1.2  
  ( 0 to 3 )  
2 weeks after treatment     1.5  
  ( 0 to 3 )  

No statistical analysis provided for Numerical Range Scale (NRS) of Pain Level



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

Measure Type Secondary
Measure Title Discomfort Level
Measure Description Patient's self-assessed discomfort level on a 4-point scale, with: 0 = no pain; 1 = mild; 2 = moderate; 3 = severe.
Time Frame Treatment Day: Baseline, Recovery, Discharge; Follow-up: 24 hours, 48 hours, 72 hours, 1 week, 2 weeks  
Safety Issue No  

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.

Subjects were included into analysis at a given time point if they had not received hysterectomy yet prior to that time point.

Analysed subject numbers were:

from baseline up to including 72 hours: 11 subjects (per protocol population); at 1 week: 6 subjects; at 2 weeks: 4 subjects;


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  
Number of Participants Analyzed  
[units: participants]
  11  
Discomfort Level  
[units: units on a scale]
Mean ( Full Range )
 
Treatment Day: Baseline     0.7  
  ( 0 to 2 )  
Treatment Day: Recovery     0.8  
  ( 0 to 2 )  
Treatment Day: Discharge     0.5  
  ( 0 to 2 )  
24 hours after treatment     0.8  
  ( 0 to 2 )  
48 hours after treatment     0.6  
  ( 0 to 2 )  
72 hours after treatment     0.7  
  ( 0 to 2 )  
1 week after treatment     0.3  
  ( 0 to 1 )  
2 weeks after treatment     1.3  
  ( 0 to 3 )  

No statistical analysis provided for Discomfort Level




  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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