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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040003 S006/ PAS001 |
| Date Original Protocol Accepted |
04/19/2010
|
| Date Current Protocol Accepted |
04/19/2010
|
| Study Name |
Exablate 2100 Type 1.0
|
| Device Name |
EXABLATE 2100 SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary goal of the study is to evaluate the incidence of post-procedure significant leg pain for the ExAblate treatment of uterine fibroids using enhanced sonication. Leg pain analysis will test non-inferiority of the ExAblate test group versus an incidence reference of 7%, allowing for a non-inferiority delta of 10%.
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| Study Population |
Pre or peri-menopausal women who are not pregnant or breastfeeding, ages 18 and over, are seeking treatment for fibroid symptoms will be evaluated and invited to participate in the study.
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| Sample Size |
A total of one hundred and fifteen (115) patients will be enrolled and treated. This study analysis of post-procedure significant leg pain will be based on the incidence of 7 percent suggested by FDA. Per FDA suggested sample calculation based on the non-inferiority one-sided alpha of 0.025, the sample estimate based on assumptions of type I error (alpha) = 0.025, type II error (beta (power)) = 0.86, an incidence of 7%, a non-inferiority delta of 0.10 resulted in a required sample size of 96. Allowing for a dropout rate of 20% results in a sample size of N = 115¿
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| Key Study Endpoints |
Safety data will be collected, including the type, frequency, and severity of adverse events (see Attachment A for more details).
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| Follow-up Visits and Length of Follow-up |
Patients will be followed at one week and one month.
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| Interim or Final Data Summary |
| Interim Results |
Final Report accepted, sponsor was advised to submit labeling change supplement. Study will be marked as completed when the labeling change supplement is approved.
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| Actual Number of Patients Enrolled |
115 subjects enrolled and treated
|
| Actual Number of Sites Enrolled |
7
|
| Patient Follow-up Rate |
94% at 1-month
|
| Final Safety Findings |
There was a substantially higher occurrence of pain in the post-approval study (PAS) compared to the pivotal study. In the pivotal study the most common adverse events were as follows: abdominal pain (38.5%); Other pain (12.8%); and positional back pain (10.1%). Sonication-related pain in the leg and back were relatively less common (7.3% and 3.7%, respectively). Pain was also a common adverse event in the post-approval study and occurred more frequently than in the pivotal trial. The most commonly occurring types of pain in the PAS were as follows: sonication-related abdomen pain (52.1%); sonication-related leg pain (28.9%); and sonication-related back pain (14.9%). The most common adverse events were back/buttock/leg pain, abdominal pain, and skin pain (all sonication-related). Of the 366 adverse events, 306 (84%) were mild or moderate and 60 (16%) were severe. The most common severe adverse events were Pain Abdomen Sonication-related, Pain Back/Buttock/Leg ¿ Sonication-related, and Skin Pain Sonication-related. Seventy-six percent of all adverse events resolved on the day of treatment, and 88% of all events resolved within 10 days of treatment.
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| Final Effect Findings |
No effectiveness endpoints in this study
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| Study Strengths & Weaknesses |
High follow-up rate of 94%.
Multi-center design increases representativeness of the study sample.
Limitations
The high screen failure rate limits the generalizeability of the PAS findings to women with uterine fibroids at large.
Short follow-up period of 1 month.
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| Recommendations for Labeling Changes |
Yes
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