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.
More than 10% of the primary endpoint data missing
General Study Protocol Parameters
Prospective & Retrospective Study
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Concurrent & Historical Control
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
Subjects who undergo a spinal procedure where DuraSeal¿ Exact Spine Sealant (DuraSeal¿ Sealant arm only)
or Standard of Care (control arm only) is administered for the treatment of either an intentional or incidental opening of the dura. All subjects who meet the eligibility criteria will be invited to participate in the study.
¿ Subject is 18 years of age or older
¿ Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:
o DuraSeal¿ Exact Spine Sealant (DuraSeal¿ Sealant group ONLY) or
o Any other method of sealing the dura with the exception of DuraSeal¿ Sealant -either spinal or cranial. (Control group ONLY)
¿ Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.
o Prospective subjects: Consent must be obtained within 24 hours of surgery stop time.
o Retrospective subjects (Control group specific): IRB approval may be granted to individual sites to waive requirement for informed consent.
A total of 884 subjects need be enrolled. Both treatment arms will enroll up to
442 subjects in order to obtain a total of 365 evaluable subjects with 90 day follow-up data for each treatment group.
1 : 1 allocation of treatment to control, and (5) ðT = ðC = 0.08. The required sample sizes for each group were calculated based on the use of the normal approximation test for testing non-inferiority between two population proportions. Based on these assumptions, it was determined that 402 DuraSeal¿
Exact Spine Sealant patients and 365 Control patients would be needed. In order to compensate for some additional variability due to the propensity score adjustment, these sample sizes were both increased by 10% to 402 in each arm, respectively. Assuming a 10% dropout rate within each treatment group, these numbers were further increased to 442 DuraSeal¿ Exact Spine Sealant patients and 442 control patients.
If, prior to completion of enrollment of the 442 DuraSeal¿ Exact Spine Sealant patients or the 442 Control patients, the desired number of completed patients (402 or 402, respectively) is obtained in either arm, enrollment in that arm would cease. A patient will be considered completed if there is follow-up of at least 60 days.
The primary endpoint is the occurrence of post-operative CSF
leaks within 90 days after the spine
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