Post-Approval Studies

Post-Approval Studies

• 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.

Links

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• Tools for Conducting PAS
• Letter to IRB Chairs (formerly referred to as "IRB Letter from Dr. Schultz (dated 2/9/09)"
• Letter to PAS Participants
• Letter to PAS Investigators
• Post-Approval Studies Workshops
• Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General

Application Number

P010047 S010

Protocol Approved

03/19/2012

Study Name

NeoMend ProGel Pleural Air Leak Sealant

Study Status

Progress Adequate

General Study Protocol Parameters

Study Design

Case Control Study

Study involve follow-up of premarket cohort (Y/N)

No

Data Source

New Data Collection

Comparison Group

Concurrent Control

Analysis Type

Descriptive

Study Population

Transitional Adolescent A: 18-21 yrs, Transitional Adolescent B: 18-21 yrs, Adult: >21

Detailed Study Protocol Parameters

Study Design Description

Prospective, observational cohort study with a ProGEL Sealant group and a comparison group of standard-of-care.

 

Study Population Description

267 ProGEL Sealant + 133 Comparison Group. Subjects in the comparison group follow the current

standard of care to treat IOAL after lung resection is defined by techniques involve suturing, stapling, and cauterization of the lung parenchyma where the leak is detected

 

Sample Size

267 ProGEL Sealant + 133 Control

Data Collection

Study Endpoints 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

90 days

NeoMend ProGel Pleural Air Leak Sealant Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Reporting Status
six month report	06/20/2012	08/22/2012	Overdue/Received
one year report	01/13/2013	01/14/2013	Overdue/Received
two year report	01/13/2014
three year report	01/13/2015
four year report	01/13/2016
five year report	01/13/2017

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