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
Study subjects are individuals enrolled in IDE study with a history of chronic fecal incontinence
who failed or were not candidates for more conservative treatments. Subjects serve as self controls.
Sample Size
285 subjects, 12 sites
Followup Visits and Length of Followup
5 years post implant
Yearly up until at least 5 years post implant
Final Study Results
Actual Number of Patients Enrolled
120
Actual Number of Sites Enrolled
13
Patient Followup Rate
60% (72/120)(Rate included 14 subjects who were lost due to death of Principal Investigator and
5
died of causes unrelated to the device or therapy)
Final Safety Findings
There were no specific study safety endpoints in this post approval study. Safety was monitored
in a purely descriptive fashion. There were 21 serious device/therapy related adverse events and
351 non-serious device or therapy related adverse events, many of which required surgical intervention.
Over the course of the study that there were 10 device revisions among 10 subjects, 40 device replacements among 29 subjects and 22 device explants among 22 subjects. The overall device revision and replacement rate was 24.4%, and the overall device explantation rate was 19%. The all cause surgical intervention rate for the 120 enrolled subjects was 35.6% for the first 5 years
Final Effectiveness Findings
Primary Endpoint: Incontinent Episoides ( ¡Ý50% improvement from baseline): Proportion of Successes: 69% (95%CI- 60%-77%),
based on last observation carried forward imputation method for missing subjects
Study Strengths and Weaknesses
Strength: Prospective hypothesis driven study, high level of quality control, multiple effectiveness outcomes evaluated including
patient centered disease specific QoL questionnaires.
Weakness: High loss to follow-up, no study safety hypothesis.
