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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
History of Changes
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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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) ]
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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
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  Other Adverse Events
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Time Frame Feb 9, 2009 through March 9, 2010
Additional Description

Adverse events assessed by patient questionnaire.

Only unexpected adverse events were reported in the "Other" Adverse Event Field.

All adverse events were reported including those not related to treatment.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
HIFU Treatment No text entered.

Other Adverse Events
    HIFU Treatment  
Total, other (not including serious) adverse events    
# participants affected / at risk     6/11  
Gastrointestinal disorders    
Rectal Bleeding † 1 [3]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Diarrhea † 1 [4]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Nausea † 1 [5]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Constipation † 1 [6]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
General disorders    
Pruritis † 1 [5]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Fever † 1 [7]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Cold † 1 [7]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Injury, poisoning and procedural complications    
Sharp burning pain at abdomen † 1 [8]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Musculoskeletal and connective tissue disorders    
Neck Pain † 1 [9]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Pain at Rib Cage or Chest Level † 1 [10]  
# participants affected / at risk     2/11 (18.18%)  
# events     4  
Right leg pain † 1 [11]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Lower back pain † 1 [12]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Shin discomfort † 1 [13]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
pain right buttock † 1 [8]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Shoulder pain † 1 [14]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Right foot swelling † 1 [15]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
Reproductive system and breast disorders    
Fatigue † 1 [5]  
# participants affected / at risk     1/11 (9.09%)  
# events     1  
† Events were collected by systematic assessment
1 Term from vocabulary, Descriptive
[3] Bleeding unlikely caused by treatment
[4] Unlikely related to procedure
[5] Not related to treatment
[6] Not related
[7] Caught a cold before treatment
[8] possibly related to treatment
[9] Neck pain caused by positioning during treatment
[10] Pain caused by positioning during treatment
[11] pain possibly due to positioning during treatment
[12] Pain most likely due to positioning during treatment
[13] Definitely related
[14] probably related to treatment positioning
[15] possibly related



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Sarah Baxter
Organization: Philips Healthcare
phone: 425-487-7665
e-mail: sarah.baxter@philips.com


Publications:

Publications automatically indexed to this study:


Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT00837161     History of Changes
Other Study ID Numbers: 994043
Study First Received: February 4, 2009
Results First Received: July 1, 2011
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration