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.
Site enrollment milestones not met,
Subject enrollment milestones not met
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Device Subjects Serve as Own Control
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
New enrollment study designed to evaluate the safety and effectiveness of
Lap-Band. Prospective single-arm cohort.
Study Population Description
Patients with BMI >=30 kg/m2 and <40 kg/m2 and 1 or more obesity-
related comorbidities. There
is no control group in this study.
325 subjects will be enrolled across 20 U.S. sites. Assuming 20% attrition, a sample size
of 260 subjects at 5 years provides 84% power to test the hypothesis that the reduction in diabetes prevalence at 5 years will be at least 5%. This will be tested using a 1-sided exact binomial test with a 5% significance level. Up to 65 subjects can be enrolled per site.