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
This is an open label, prospective, observational study of performance and programming of the RNS
Study Population Description
Subjects implanted with the RNS System who are 18 years of age
or older with partial
onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to 2 or more antiepileptic medications, and currently have frequent and disabling seizures.
No comparator group.
A total of 375 subjects may be enrolled in order to have for
evaluation a minimum
of 300 evaluable patients
Approximately 30 study sites
Part 1: Performance
1.1 Severe adverse event rate within sub-populations
1.2 Median percentage reduction in seizures within
Part 2: Programming
2.1 SAE rates based on neurosurgeon and physician experience
2.2 mean seizure rate at for each programming parameter
Followup Visits and Length of Followup
The study consists of 3 time periods (a) pre-implant, including enrollment and initial clinical
appointment; (b) initial implant, and (c) post-implant follow-up clinical appointments up 18 times to the end of the study.
New Enrollment - Performance & Programming