Status:
COMPLETED
Therapeutic MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids
Lead Sponsor:
Philips Healthcare
Conditions:
Uterine Leiomyomas
Eligibility:
FEMALE
18-59 years
Phase:
PHASE3
Brief Summary
This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fib...
Detailed Description
Fibroids occur in 20-50% of women over 30 years of age, and with increasing size produce pain, menorrhagia, pressure, bloating and urinary and bowel compression symptoms. Fibroids may also cause infer...
Eligibility Criteria
Inclusion
- Women, age between 18 and 59 years
- Weight \< 140kg
- Pre- or peri-menopausal
- Uterine size \< 24 weeks
- Transformed SSS score \> 40
- Normal Cervical cell assessment by PAP
- Symptomatic Fibroid disease
- Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm
Exclusion
- Other Pelvic Disease
- Desire for future pregnancy
- Significant systemic disease even if controlled
- Positive pregnancy test
- Hematocrit \< 25%
- Scarring or other interference of the HIFU beam
- MRI or contrast contraindicated
- Fibroids not quantifiable on MRI
- Calcifications around or throughout uterine tissues
- Communication barrier
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01141062
Start Date
June 1 2010
End Date
October 1 2011
Last Update
December 4 2012
Active Locations (2)
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1
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
2
Sunnybrook Health Sciences Centre, University of Toronto
Toronto, Ontario, Canada, M4N 3M5