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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
Objective: Estimate the rates of post-operative CSF leak, deep surgical site infection and neurological SAEs
within 90 days for DuraSeal Exact Spine Sealant and to compare these rates to the corresponding rates for Control. Design: a multi-center, non-randomized, Post Approval study with a prospective treatment arm and a retrospective control arm.
Study Population Description
For the retrospective controls (standard of care), subjects with fewer than 45 days of follow-up
will be considered incomplete.
The DuraSeal Exact Spine Sealant prospective treatment arm will enroll up to 489 subjects in
order to obtain a total of 402 evaluable subjects with 90 day follow-up data.
The primary endpoint is the occurrence of post-operative CSF leaks within 90 days after the
spine surgical procedure.
A CSF leak is defined as a CSF fistula or a pseudomeningocele* confirmed by clinical examination or diagnostic testing (i.e., MRI or CT) whether or not treatment such as surgical repair or drainage is required.
* Pseudomeningocele noted on a diagnostic test must be confirmed by the study investigator
Secondary endpoints are the occurrence of the following events (within 90 days following the surgical procedure):
Deep Surgical Site Infections (DSSI) as defined per the CDC guidelines
All neurological SAEs
Followup Visits and Length of Followup
For retrospective controls (standard of care), a patient will be considered completed if there is
follow-up of at least 45 days.
New study sites that do not have 90 day standard of care visits will enroll prospective subjects only (DuraSeal and/or Control). This would allow new sites to contribute subjects prospectively inside the study window (60 to 120 days), and allow control over follow-up compliance.
OSB Lead-DuraSeal Exact Spine Sealant System