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.
This multi-center, non-randomized study with a prospective treatment arm and a retrospective control arm
Study Population Description
Subjects who undergo a spinal procedure where DuraSeal Exact Spine Sealant (prospective arm only) or
Standard of Care (retrospective control arm only) is administered for the treatment of either an intentional or incidental opening of the dura
treatment arm and control arm
The primary endpoint is the occurrence of post-operative CSF leaks within 90 days after the
spine surgical procedure. Secondary endpoints are the occurrence of the following events (within 90 days following the surgical procedure): 1) Deep Surgical Site Infections (DSSI) as defined per the CDC guidelines; 2) All neurological SAEs