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 is an observational cohort study. A new cohort of patients and physicians will be
enrolled to collect procedural data on ESS305. Data from the Study for Newly Trained Physicians (completed September 2005) will be used as the comparator. The protocol also includes collection of adverse events data.The purpose of this post-approval clinical study is to determine the following: 1. Bilateral placement ofthe ESS305 micro-insert at first attempt; 2. Comparison of bilateral placement success between NewlyTrained physicians and Experienced physicians 3. Identification of factors predictive of failure to achieve bilateral placement ofthe ESS305 micro-insert al first attempt; 4. Evaluation of aspects ofthe ESS305 design that may impact bilateral placement rate; 5. Hysteroscopy time to perform the procedure 6. Adverse device effects; and 7. Adverse procedure events.
Study Population Description
Study population is as per device indication. This device is indicated for permanent birth control
(female sterilization) by bilateral occlusion of the fallopian tubes in adult women seeking permanent birth control.
Sample Size
657 women enrolled - protocol states 20 sites enrolled patients
Data Collection
Study endpoints include: (1) bilateral micro-insert placement rate, (2) identification of factors predictive of micro-insert
placement failure, (3) evaluation of aspects of the ESS305 design that may impact bilateral placement rate; and (4) hysteroscopy time to perform the procedure.
Followup Visits and Length of Followup
N/A
Final Study Results
Actual Number of Patients Enrolled
584 women
Actual Number of Sites Enrolled
76
Patient Followup Rate
81.60%
Final Safety Findings
The sponsor reported only 6 adverse events occurred during and after the Essure placement procedure
(6 out of 584). All reported events were minor with the exception of one case. The subject was hospitalized after hysteroscopy resulted in a uterine perforation by the hysteroscope. The sponsor claims the Essure device did not cause the injury to the patient. None of these events represent unanticipated adverse device effects.
Study Strengths and Weaknesses
The study is well designed to evaluate the placement rate among newly trained physicians at
first attempt, when implanting the device in women seeking permanent sterilization.
Recommendations for Labeling Changes
Update labeling with the results of the study in the context of patient and physician labeling.
