Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Ki vehet részt

• MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
• Fibroids selected for treatment meet the following criteria; Total planned ablation volume of all fibroids should not exceed 500 ml AND; Completely non-enhancing fibroids should not be treated
• Transformed SSS score >= 40
• Pre- or peri-menopausal, as indicated by clinical evaluation
• Weight < 140 kg or 310 lbs
• Willing and able to attend all study visits
• Willing and able to use reliable contraception methods
• Uterine size < 24 weeks
• Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
• Waist circumference <110cm or 43 inches

Ki nem vehet részt

• Surgical clips in the potential path of the HIFU beam
• Patients with coagulopathy or under current anti-coagulation therapy
• Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
• MRI contrast agent contraindicated (including renal insufficiency)
• Patient with unstable medical conditions
• Positive pregnancy test
• Extensive scarring along anterior lower - abdominal wall (>50% of area)
• Tattoos in the potential path of the HIFU beam
• MRI contraindicated
• Calcification around or throughout uterine tissue that may affect treatment
• Communication barrier
• Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible)
• Pedunculated fibroids
• Bowel loops int he ultrasound beam path
• Patients with inability to tolerate prolonged prone position for up to 3 hours