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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040003 S015/ PAS001 |
| Date Original Protocol Accepted |
08/31/2015
|
| Date Current Protocol Accepted |
07/23/2025
|
| Study Name |
Post ExAblate Pregnancy Outcomes Registry
|
| Device Name |
EXABLATE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is an observational [single cohort] global Post-ExAblate Pregnancy Outcome Registry-based Study. The objective is to collect safety information regarding patient pregnancy/outcomes following treatment of their symptomatic fibroid(s) with the ExAblate MR guided focused ultrasound system. All adverse events that are possibly related to pregnancies and pregnancy outcomes, including post-partum complications for both mother and infant, will be collected in consenting patients.
|
| Study Population |
All consented patients from participating sites who receive an ExAblate procedure or have previously undergone an ExAblate procedure for symptomatic uterine fibroids will be recruited for this registry. There is no control group.
|
| Sample Size |
The registry is open to all who would consent at participating sites, and will be open for enrollment for two years. The study aims to enroll up to 198 patients in total. A minimum of ten sites from around the world will participate, including a minimum of six sites from the U.S.
|
| Key Study Endpoints |
Main safety endpoint: Adverse events related to pregnancies, including but not limited to pregnancy outcome, and post-partum complications for the mother and infant. The nature of each adverse event, date and time (when appropriate) of onset, outcome, frequency, maximum intensity, action taken, expectedness, and causal relationship will be recorded.
|
| Follow-up Visits and Length of Follow-up |
Up to two years after ExAblate treatment, or until pregnancy completion.
Sites should contact the subject 2 times a year (approximately every 6 months) for 2 years after the ExAblate procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
198 patients
|
| Actual Number of Sites Enrolled |
9 sites
|
| Patient Follow-up Rate |
Of the 198 total patients to enter the registry, 104 (53%) completed the study, and 94 exited the study. Of the 94 that exited the study, 36 subjects were exited from the study due to a center shutting down, 14 were lost to follow up, 8 due to Exablate treatment failure, 3 due to patient decision, 4 were not qualified, 4 were non-compliant, 4 withdrew consent, 2 completed child-bearing, 5 had myomectomies, 4 had hysterectomies, and 11 had others reason for exiting the study.
|
| Final Safety Findings |
There were 20 pregnancies, four miscarriages and 16 deliveries reported in the study cohort, resulting in a miscarriage rate of 20% (4/20). Five out of sixteen (31%) of deliveries were vaginal deliveries, with 11/16 (69%) of deliveries through C-section. Six adverse events were reported in the pregnancy cohort, which included events during pregnancy and post-partum. One reported pregnancy complication related to a conversion from vaginal delivery to Cesarean section was considered possibly related to the device.
|
| Final Effect Findings |
No effectiveness endpoints in this study
|
| Study Strengths & Weaknesses |
The strengths of the study are enrollment at multiple diverse sites. The weakness of the study includes high attrition due to site closures and loss to follow up, 91 out of 198 patients exited the study, which may increase bias in study results. Due to the observational structure of the study, study results are not inferential in nature, and definitive conclusions regarding relative rates of adverse events cannot be made.
|
| Recommendations for Labeling Changes |
No
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