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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study to Evaluate Safety of ExAblate

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Study Status Completed
Application Number P040003 S016/ PAS001
Date Current Protocol Accepted  
Study Name Study to Evaluate Safety of ExAblate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Ongoing enrollment in multi-center, prospective, single arm study to evaluate safety of the ExAblate Model 2100 Type 1.1 System.
Study Population Description 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.
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.

Data Collection 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

Follow-up Visits and Length of Follow-up 1 month post-procedure

1 Week and 1 month post-procedure
Interim or Final Data Summary
Actual Number of Patients Enrolled 136
Actual Number of Sites Enrolled 8
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
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.
Final Effect Findings Increase in the average non-perfused volume (per total fibroid volume) compared to the current ExAblate system
Study Strengths & Weaknesses n/a
Recommendations for Labeling Changes The labeling will be updated to include follow up outcomes.

Study to Evaluate Safety of ExAblate Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report/final report 10/04/2016 10/07/2016 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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