Uterine Fibroids
Conditions
Keywords
Uterine fibroids, MRgFUS, ExAblate, Focused Ultrasound, Symptomatic uterine fibroids
Brief summary
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins. The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids. The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.
Interventions
DEVICEExAblate
Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
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
No
Inclusion criteria
* Women age 18 or older * Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) * Women who have given written informed consent * Women who are able and willing to attend all study visits. * Patient is pre or peri-menopausal (within 12 months of last menstrual period). * Patient should be family complete. * Able to communicate sensations during the ExAblate procedure. * 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). * Fibroids(s) clearly visible on non-contrast MRI. * Fibroid enhances on MR contrast imaging.
Exclusion criteria
* Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. * Patients who are breast-feeding. * Patients with active pelvic inflammatory disease (PID). * Patients with active local or systemic infection. * Patients experiencing chronic leg or lower back pain within the last 6 months. * Contraindication for MRI Scan: * Severe claustrophobia that would prevent completion of procedure in the MR unit * Weight greater than 250 lbs (113Kg) * Implanted ferromagnetic materials and/or devices contraindicated for MR scan * Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist) * Any other contraindication for MRI Scan * Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam). * Dermoid cyst of the ovary anywhere in the treatment path. * Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia. * Intrauterine device (IUD) anywhere in the treatment path. * Undiagnosed vaginal bleeding. * Pedunculated fibroids. * Uterine size \>24 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Occurrence of Chronic Leg Pain | From treatment to 1-month post-treatment | The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit \> 0.90 was considered statistically successful. |
Countries
United States
Participant flow
Pre-assignment details
The protocol defined the primary analysis to include participants receiving more than 1 sonication, i.e., 115 in this case. The safety population was defined in the protocol as participants receiving any sonications which is 121. 6 subjects receiving only 1 sonication were in the safety population but not in the baseline or primary analysis.
Participants by arm
| Arm | Count |
|---|---|
| ExAblate Treatment ExAblate: Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Alternative Treatment | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Received only 1 sonication | 0 | 6 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | ExAblate Treatment |
|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 5.6 |
| Race/Ethnicity, Customized Asian | 8 Participants |
| Race/Ethnicity, Customized Black | 14 Participants |
| Race/Ethnicity, Customized European/Middle East (White) | 84 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Region of Enrollment United States | 115 participants |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 121 |
| other Total, other adverse events | 105 / 121 |
| serious Total, serious adverse events | 0 / 121 |
Outcome results
Primary
Percent Occurrence of Chronic Leg Pain
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit \> 0.90 was considered statistically successful.
Time frame: From treatment to 1-month post-treatment
Population: Per protocol the number of participants analyzed was the number of participants receiving more than one sonication. Six subjects receiving one sonication were excluded from the primary analysis but included in the safety population for a safety sample size n = 121.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ExAblate Treatment | Percent Occurrence of Chronic Leg Pain | 97 percentage of subjects without leg pain |