Status:
COMPLETED
Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
InSightec-TxSonics
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00159328
Start Date
March 1 2003
End Date
December 1 2006
Last Update
August 13 2008
Active Locations (1)
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1
Department of Interventional Magnetic Resonance, St Mary's Hospital
London, United Kingdom, W2 1NY