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
The study is a prospective observational study to collect safety information about the IBV Valve
System for the treatment of prolonged air leak. Eligible subjects will be enrolled into the study on the day of valve treatment. The subjects will be monitored after treatment until discharge from the hospital (a minimum of 1 night stay after the procedure). After discharge, the subjects will be seen by the investigator for assessment of air leak status as clinically indicated. Valves will be removed after the air leak is resolved. If the air leak is not resolved, the valves will be removed no longer than 6 weeks after device placement and other options can be considered.
Study Population Description
Study Population: Patients with prolonged air leaks of the lung, or significant air leaks that
are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery. Indication: The Spiration IBV Valve System is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery.
Sample Size
32 patients,15 sites
Data Collection
The safety endpoints include the total number, rate, type, timing, duration, severity and relationship to
device or procedure of adverse events. Probable benefit data includes: 1) A positive response in air leak resolution; 2) Number of days after valve placement until air leak resolution; 3) Number of days in intensive care or critical care unit after valve placement; 4) Number of days after valve placement until discharge from the hospital; and 5) Number of days between valve placement and valve removal.
Followup Visits and Length of Followup
The duration of follow-up is a maximum of 6 weeks. The subjects will be followed
through the earlier of valve removal or 6 weeks after device placement.
