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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Exablate 2100 Type 1.0


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General
Application Number P040003 S006/ PAS001
Current Plan Approved 04/19/2010
Study Name Exablate 2100 Type 1.0
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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%.
Study Population Description 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.
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¿
Data Collection Safety data will be collected, including the type, frequency, and severity of adverse events (see Attachment A for more details).
Follow-up Visits and Length of Follow-up Patients will be followed at one week and one month.
Final Study Results
Interim Safety Information Final Report accepted, sponsor was advised to submit labeling change supplement. Study will be marked as completed when the labeling change supplement is approved.
Number of Patients 115 subjects enrolled and treated
Number of Sites 7
Follow-up Rate 94% at 1-month
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.
Effect Findings No effectiveness endpoints in this 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.
Label Changes Yes


Exablate 2100 Type 1.0 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/21/2010 10/20/2010 Overdue/Received
1 year report 03/23/2011 04/15/2011 Overdue/Received
18 month report 09/21/2011 09/21/2011 On Time
2 year report 03/22/2012 04/04/2012 Overdue/Received
3 year report-final report 03/22/2013 04/12/2013 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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