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

MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony - MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.

Inclusion Criteria:

1. MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated

2. Fibroids selected for treatment meet the following criteria

   1. Total planned ablation volume of all fibroids should not exceed 500 ml AND
   2. Completely non-enhancing fibroids should not be treated

3. Transformed SSS score >= 40

4. Pre- or peri-menopausal, as indicated by clinical evaluation

5. Weight < 140 kg or 310 lbs

6. Willing and able to attend all study visits

7. Willing and able to use reliable contraception methods

8. Uterine size < 24 weeks

9. Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue

10. Waist circumference <110cm or 43 inches

Exclusion Criteria:

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