Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids

Imperial College London

Status and phase: Completed; Phase 4

Conditions: Uterine Fibroids

Treatments: Procedure: Magnetic Resonance Guided Focused Ultrasound

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00159328

UF008

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)