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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


  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 ]

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
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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.


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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT00837161     History of Changes
Other Study ID Numbers: 994043
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: July 1, 2011
Results First Posted: November 28, 2011
Last Update Posted: December 4, 2012