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 400쳌]subject (), non쳌]randomized, prospective, multi쳌]center post쳌]approval study with the aim to
compare the proportion of outcome measures (including adverse events in specified pulmonary, renal and cardiovascular categories, all cause mortality, rates of hospital readmission) between subjects with ProGEL Sealant and subjects with ). The recruitment is a block recruitment of a minimum of 3 by 6 patients per clinical site (protocol amendment: Protocol#NEO09쳌]100/Amendment 1).
Study Population Description
All subjects has been scheduled for an open thoracotomy for lung resection (lobectomy, bilobectomy, segmentectomy,
wedge resection) with 30 days of the screening evaluation, is (b) (4)
(b) (4) (b) (4)
(b) (4) (b) (4)
18 years or older and is willing and able to complete the entire study as specified in the protocol, including the follow쳌]up visits, has at least one or more intraoperative visible air leak (> 2mm) following the lung resection surgery. All subjects are not pregnant or breast feeding, do not have a history of an allergic reaction to Human Serum Albumin, do not have significant clinical disease or condition (e.g., cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematological, psychiatric or neurologic), are not enrolled in any other study involving tissue sealant materials, do not have an ECOG performance status score of 3 or greater and do not have previous open thoracotomy procedures (e.g., reoperations).
In addition, subject are able to understand the study procedures and either the patient, patient's guardian, or legally appointed representative has signed the Informed Consent Form
Sample Size
400-subject () and recruited from up to 20 sites in the United States.
Data Collection
1. Pneumothorax
2. Air leak, persistent
3. Air leak, late onset
4. Residual pleural space
5. Acute respiratory distress syndrome (ARDS)
6. Post-surgical renal abnormalities
7. Myocardial infarction
8. Atrial
arrhythmia requiring treatment
9. Ventricular arrhythmia requiring treatment
10. Cardiac arrest (resuscitated)
11. Death (all causes)
12. Hospital readmission (related to pulmonary surgery)
Followup Visits and Length of Followup
30 (쳌}7) and 90 (쳌}14) days.
The assessments include stipulated adverse event occurrences or any hospitalizations
since discharge, undergo a study-specific chest X-ray for assessment of residual pleural space and any complications, and have blood drawn for CBC, electrolytes, BUN and creatinine.
