Uterine Fibroids, Uterine Leiomyoma
Conditions
Keywords
Fibroids, leiomyoma, neoplasm, benign tumors
Brief summary
This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
Detailed description
Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.
Interventions
DEVICEExAblate Enhanced Sonication
Sponsors
InSightec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Women age 18 or older, who present with symptomatic fibroids 2. Women who have given written informed consent 3. Women who are able and willing to attend all study visits. 4. Patient is pre or peri-menopausal (within 12 months of last menstrual period). 5. Able to communicate sensations during the ExAblate procedure. 6. 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). 7. Fibroids(s) clearly visible on non-contrast MRI.
Exclusion criteria
1. Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment 2. Patient who desire to become pregnant in the future. 3. Patients who are breast-feeding. 4. Patients with an active pelvic inflammatory disease (PID) 5. Active local or systemic infection 6. Metallic implants that are incompatible with MRI 7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) 8. Severe claustrophobia that would prevent completion of procedure in the MR unit. 9. Extensive abdominal scarring in the beam pass or 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. Pedunculated fibroids. 12. Intrauterine device (IUD) anywhere in the treatment path 13. Undiagnosed vaginal bleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | Within 1 month of treatment | The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Enhanced Sonication Normalized Thermal Dose Volume | During treatment | The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging. |
| Number of Participants With Adverse Events | Within 1 month of treatment | — |
Countries
Canada, United States
Participant flow
Pre-assignment details
Out of the 83 subjects signing consent, 33 subjects failed additional study requirements and did not participate. Fifty (50) subjects were treated; 48 received enhanced sonications, 2 received only nominal sonications.
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Sonication Test Arm ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-compliance | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Enhanced Sonication Test Arm |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 5.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment Canada | 11 participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 35 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Number of Adverse Events
The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Time frame: Within 1 month of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enhanced Sonication Test Arm | Number of Adverse Events | Total Adverse Events | 77 Adverse Events |
| Enhanced Sonication Test Arm | Number of Adverse Events | Mild/Moderate Adverse Events | 75 Adverse Events |
Other Pre-specified
Mean Enhanced Sonication Normalized Thermal Dose Volume
The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.
Time frame: During treatment
Population: Of the 50 subjects treated, 39 were included in the thermal analysis per the protocol. Of the 11 subjects not eligible, 8 were not treated with at least 30% enhanced sonications. Three subjects received enhanced sonications at tissue depths greater that 70 mm from the skin line.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Sonication Test Arm | Mean Enhanced Sonication Normalized Thermal Dose Volume | 0.67 cc/KJ/sonication | Standard Deviation 0.35 |
Other Pre-specified
Number of Participants With Adverse Events
Time frame: Within 1 month of treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Sonication Test Arm | Number of Participants With Adverse Events | Subjects with no AEs reported | 13 Participants |
| Enhanced Sonication Test Arm | Number of Participants With Adverse Events | Subjects reporting AEs | 35 Participants |
| Enhanced Sonication Test Arm | Number of Participants With Adverse Events | Subject deaths | 0 Participants |
| Enhanced Sonication Test Arm | Number of Participants With Adverse Events | Subjects with SAE reported | 0 Participants |