Status:
COMPLETED
Pilot Study of MRI-Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Lead Sponsor:
Philips Healthcare
Conditions:
Uterine Fibroids
Uterine Leiomyomata
Eligibility:
FEMALE
18-59 years
Phase:
PHASE1
PHASE2
Brief Summary
Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new...
Detailed Description
Uterine fibroids (leiomyomas) are a common cause of heavy uterine bleeding and pain in reproductive aged women and are the most common cause of hysterectomy in the United States. Women are seeking new...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Recommended for Total Abdominal Hysterectomy
- Age between 18 and 59
- Weight less than 140kg (or 310lbs)
- Pre or peri menopausal with FSH less than 40 mIU/ml
- Uterine size less than 24 weeks based on MRI and physical exam assessment
- Symptom severity score greater than or equal to 50 by Spies Uterine Fibroid Questionnaire.
- Cervical cytology no more severe than low grade SIL
- History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994):
- Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 16 cm on imaging.
- EXCLUSION CRITERIA:
- Other pelvic disease (mass indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease)
- Desire for future pregnancy
- Significant systemic disease even if controlled
- Pregnant or Positive pregnancy test
- Hematocrit less than 25%
- Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU beam
- MRI or MRI contrast agent contraindicated
- Unable to quantify or measure fibroids on MR exam including nonenhancing fibroids
- Fibroid or uterine calcifications
- Dominant fibroid is pedunculated or greater than 5 cm submucosal
- Communication barrier
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00837161
Start Date
January 1 2009
End Date
December 1 2010
Last Update
December 4 2012
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030