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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040003 / PAS001 |
| Date Original Protocol Accepted |
10/22/2004
|
| Date Current Protocol Accepted |
10/22/2004
|
| Study Name |
Long Term Exablate Study
|
| Device Name |
EXABLATE 2000 SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study was design to provide descriptive data on the long term performance (safety and effectiveness) of the device. This is an observational prospective study that includes the extended follow-up of the premarket cohorts and enrollment of a new cohort of African American women who were treated following the commercial treatment guidelines. The study does not include a comparison group. However, before and after treatment comparisons are made.
|
| Study Population |
Study population is as per device indication. This device is indicated for ablation of uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and have completed child bearing.
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| Sample Size |
269 from premarket cohorts; 75 African American women newly enrolled postmarket
|
| Key Study Endpoints |
The study is used a standardized quality of life questionnaire for uterine fibroids (Uterine Fibroid Symptoms-Quality of Life Questionnaire). The questionnaire is administered at baseline prior to treatment and then at the follow-up visits. There is also fibroid volume data collected by MRI
|
| Follow-up Visits and Length of Follow-up |
The study includes follow-up visits at 3, 6, 12, 24 and 36-months of follow-up.
|
| 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 |
169 from premarket cohort + 73 postmarket
|
| Actual Number of Sites Enrolled |
5
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| Patient Follow-up Rate |
68.6% follow-up rate. However, those with alternative treatments, second ExAblate treatments, and/or became pregnant were discontinued from follow-up as per protocol. Therefore, long term data is only available on 32.8%
|
| Final Safety Findings |
No new device related adverse events occurred during the postmarket follow-up of the study
|
| Study Strengths & Weaknesses |
Given that the study provides long-term data on 32.8% of study participants, the results are not generalizable to the overall patient population treated with ExAblate. The treatment guidelines limited to 50% of volume size. There are currently new treatment guidelines (100%). Results under new treatment guidelines may differ.
|
| Recommendations for Labeling Changes |
Final Report is accepted. Sponsor was advised to update labeling with a new section that includes summary of the post-approval study design, results (long-term data), and study strenghts and limitations. Study will be marked as completed when labeling changes are received. Sutdy will be marked as completed when the labeling change is approved.
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