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
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.
Primary safety endpoint: 5-year explant rate; Secondary effectiveness endpoints: 5-year responder rate (where response is defined
as achieving >= 7% TBL), diabetes prevalence at 5 years, and change in obesity-related comorbidities at 5 years compared to baseline
Followup Visits and Length of Followup
10 Years - In-office visits before and after surgery, at 1, 2, 3, and 6
months, and 1, 3, 5, 7, and 10 years after surgery. Patients will complete a questionnaire at 2, 4, 6, 8, and 9 years after surgery.