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
This study is a continued follow-up of subjects in the premarket EASE trial, a prospective,
single-armed, multicenter study. The primary objective of the post-approval study is to determine the 3-year through 10-year, yearly period efficacy rates for subjects enrolled in the premarket EASE study.
Study Population Description
The device is indicated for women who desire permanent birth control (female sterilization) by occlusion
of the fallopian tubes. The study population includes women who are currently relying on the Adiana system for permanent contraception and those who are being followed for safety purposes, all from the premarket cohort.
Sample Size
770 patients, 16 sites
Data Collection
Effectiveness endpoint is the pregnancy rate during the three through ten year reliance follow-up period
for subjects in the EASE study who rely on the device for contraception.Safety endpoints include: (1) Subject satisfaction and comfort with device wearing; (2) Safety of device wearing; and (3) Relevant adverse events: All reproductive adverse events, and all abdominal adverse events reported during the study.
Followup Visits and Length of Followup
All subjects will be assessed annually in years 3, 4, 5, 6, 7, 8, 9
and 10 post reliance or follow up date (±30 days). All visits will occur via telephone. If there is any indication that the subject may be pregnant, by either verbal admission or unusual menstrual events, an office visit will be scheduled and a pregnancy test administered within one month. The duration of follow-up is ten years.
