Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids
Phase 4
Completed
- Conditions
- Uterine Fibroids
- Registration Number
- NCT00159328
- Lead Sponsor
- Imperial College London
- Brief Summary
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Symptom improvement as judged by validated disease specific questionnaire
- Secondary Outcome Measures
Name Time Method Change in fibroid and uterine volume.
Trial Locations
- Locations (1)
Department of Interventional Magnetic Resonance, St Mary's Hospital
🇬🇧London, United Kingdom