Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Uterine Fibroids
Female
Uterine Fibroids
Trial Information
Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids
Inclusion Criteria:
- Subject has given consent
- Willing and able to attend all visits
- Minimum age 18 with no desire for future fertility
- Uterine fibroid > 300 cc on MRI
- Normal cervical smear
- Screening symptom score >21
- Pre or peri-menopausal
- Fibroids being device accessible
Exclusion Criteria:
- Pregnancy
- Previous GNRH treatment
- HRT use
- Hormonal Contraception
- Patient on dialysis
- Haematocrit <25
- ASA score > 2
- Severe cerebrovascular disease
- Anticoagulated
- Active pelvic infection or history of PID
- Weight> 250 lbs
- Any contra-indication to MR imaging
- Intolerance to MRI contrast agent
- Unable to remain in prone positions for 3hours
- IUCD
- Abdominal scarring in beam pathway
- Breast feeding
- Non-perfused fibroid on contrast enhanced images
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Symptom improvement as judged by validated disease specific questionnaire
Principal Investigator
wady m gedroyc
Investigator Role:
Principal Investigator
Investigator Affiliation:
St Mary's Hospital, Imperial College London.
Authority:
United Kingdom: Research Ethics Committee
Study ID:
UF008
NCT ID:
NCT00159328
Start Date:
March 2003
Completion Date:
December 2006
Related Keywords:
- Uterine Fibroids
- Magnetic Resonance Guided Focused Ultrasound
- Gonadotrophin Releasing Hormone Agonist
- Uterine Fibroids
- Leiomyoma
- Myofibroma
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