In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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 Description
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.
Sample Size
269 from premarket cohorts; 75 African American women newly enrolled postmarket
Data Collection
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
Followup Visits and Length of Followup
The study includes follow-up visits at 3, 6, 12, 24 and 36-months of follow-up.
Final Study Results
Actual Number of Patients Enrolled
169 from premarket cohort + 73 postmarket
Actual Number of Sites Enrolled
5
Patient Followup 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
Final Effectiveness Findings
No new device related adverse events occurred during the postmarket follow-up of the study
Study Strengths and 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.
