Uterine Fibroids
Conditions
Keywords
Uterine fibroids, MRgFUS, ExAblate, Focused Ultrasound, Symptomatic uterine fibroids
Brief summary
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids. The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate. The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids. The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety: * Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid. * Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.
Interventions
DEVICEExAblate Treatment UF V2
Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
Sponsors
InSightec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patient age 18 or older 2. Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility. 3. Patients who have given written informed consent 4. Patients who are able and willing to attend all study visits 5. Patients who are pre or peri-menopausal (within 12 months of last menstrual period) 6. Patients should have completed child bearing 7. Able to communicate sensations during the ExAblate procedure. 8. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). 9. Fibroid(s) clearly visible on non-contrast MRI.
Exclusion criteria
1. Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus. 2. Uterine size \>24 weeks. 3. Patients with pedunculated fibroids 4. Patients with active pelvic inflammatory disease (PID). 5. Patients with active local or systemic infection 6. Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months 7. Contraindication for MRI Scan: * Severe claustrophobia that would prevent completion of procedure in the MR unit * Metallic implants that are incompatible with MRI * Sensitivity to MRI contrast agents * Any other contraindication for MRI Scan 8. Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam) 9. Dermoid cyst of the ovary anywhere in the treatment path. 10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia. 11. Intrauterine device (IUD) anywhere in the treatment path 12. Undiagnosed vaginal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment | From treatment to 1-month post-treatment | The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ExAblate Treatment UF V2 ExAblate MRgFUS Treatment
ExAblate Treatment UF V2: Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period. | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 2 subjects received less 10 sonications | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | ExAblate Treatment UF V2 |
|---|---|
| Age, Continuous | 46 years |
| Race/Ethnicity, Customized African American | 14 % |
| Race/Ethnicity, Customized Asian | 13 % |
| Race/Ethnicity, Customized European/Middle East (White) | 69 % |
| Race/Ethnicity, Customized Hispanic | 5 % |
| Region of Enrollment United States | 108 participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 108 |
| other Total, other adverse events | 102 / 108 |
| serious Total, serious adverse events | 1 / 108 |
Outcome results
Primary
Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
Time frame: From treatment to 1-month post-treatment
Population: Per protocol 2 subjects receiving \< 10 sonications were excluded from the safety sample size of 108 for an primary safety analysis sample size of 106.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExAblate Treatment UF V2 | Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment | 0 Percentage of participants |