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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040003 S016/ PAS001 |
| Date Original Protocol Accepted |
11/04/2015
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| Date Current Protocol Accepted |
|
| Study Name |
Study to Evaluate Safety of ExAblate
|
| Device Name |
EXABLATE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Ongoing enrollment in multi-center, prospective, single arm study to evaluate safety of the ExAblate Model 2100 Type 1.1 System.
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| Study Population |
Pre- or perimenopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure and whose uterine size is less than 24 weeks. Patients should have completed child bearing.
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| Sample Size |
Number of subjects enrolled: 106
Number of subjects required for the hypothesis test: 101 True rate of 0.03, 80% power, two-sided Type 1 error of 0.05 and 5% drop out rate.
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| Key Study Endpoints |
Primary Endpoints: Incidence of any chronic leg pain or lower extremity neuropathy, persisting or occurring greater than 10 days following ExAblate treatment and Adverse events through 1-month post-treatment
Secondary Endpoints: Fibroid ablation (number, location and volume); Average non-perfused volume; Average treatment rate; Number of executed sonications where the far field impinges on the sacral bone; and Physician qualitative assessment of new device features
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| Follow-up Visits and Length of Follow-up |
1 month post-procedure
1 Week and 1 month post-procedure
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
136
|
| Actual Number of Sites Enrolled |
8
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| Patient Follow-up Rate |
A total of 136 subjects were enrolled (i.e., consented). Of these, 30 subjects were reported to be screen failures. Of the 30 subjects that were reported to be screen failures, 2 subjects were screen failed because they only received < 10 sonications. These two subjects who received partial ExAblate treatment were included in the safety analysis. 60% of the total number of screen failures (n=18) were due to fibroid anatomy, 10% (n=3) were due to device accessibility, 13% (n=4) were subject decl
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| Final Safety Findings |
94% of study participants experienced adverse events (AE), with most participants experiencing 1-3 AEs. The sponsor noted that the frequency of AEs is similar to prior studies and that there were no new AEs or unanticipated AEs. The most commonly reported event was sonication related pain (250/339). The majority of these events were classified as moderate/severe (59%) but transient, lasting approximately 20 seconds.
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| Final Effect Findings |
Increase in the average non-perfused volume (per total fibroid volume) compared to the current ExAblate system
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| Study Strengths & Weaknesses |
n/a
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| Recommendations for Labeling Changes |
The labeling will be updated to include follow up outcomes.
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