Status:
COMPLETED
Therapeutic Magnetic Resonance Imaging (MRI)-Guided High Intensity Focused Ultrasound (HIFU) Ablation of Uterine Fibroids
Lead Sponsor:
Philips Healthcare
Collaborating Sponsors:
Philips Medical Systems
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-59 years
Phase:
NA
Brief Summary
This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance...
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 :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00897897
Start Date
April 1 2009
End Date
December 1 2009
Last Update
December 4 2012
Active Locations (4)
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1
Hospital St. Andre
Bordeaux, France
2
University Hospital Schleswig-Holstein
Lübeck, Germany
3
University Medical Center
Utrecht, Netherlands
4
Samsung Medical Center
Seoul, South Korea