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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is a prospective, single-arm, multi-center study designed to look at the long-term re-operation rates
seen with the Swedish Adjustable Gastric Band.
Study Population Description
Study population: Subjects are between the ages of 18 and 60 years old who have
been diagnosed with morbid obesity and considered appropriate candidates for surgical weight reduction. Indication: Patients with one or more significant medical conditions related to obesity for which the subject is being treated, and which are generally expected to be improved by weight loss. Body Mass Index (BMI) must be greater than or equal to 35 kg/m2 and less than or equal to 40 kg/m2.
Sample Size
300 patients, 8 sites
Data Collection
The primary endpoint is the re-operation rate (including band revisions, band replacements, and explants) in
years four and five post-implant. Secondary endpoints are: HbA1c levels, serum lipid levels, amount of excess body weight loss, quality of life measured by SF-36, Beck Depression Inventory scale score, adverse event rate, severe adverse event rate
Followup Visits and Length of Followup
Subjects will be followed for five years. During year 1 following implant, evaluations take place
at 1, 2, 4, 6, 8, and 10 months. Evaluations will then take place at 12 months, 24 months, 36 months, 48 months, and 60 months.
