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U.S. Department of Health and Human Services

Post-Approval Studies

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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

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 H120005
Most Recent Protocol Version Approved 04/25/2014
Study Name New Enrollment PAS for the Liposorber LA-15 System
Study Status Study Pending
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, single arm study with a total of 35 newly enrolled   show the rest ...
Study Population Description Pediatric patients with nephrotic syndrome associated with

primary focal segmental glomerulosclerosis, when the standard treatment options,   show the rest ...
Sample Size A total of 35 patients will be included.

The primary probable benefit endpoint will be assessed   show the rest ...
Data Collection The primary probable benefit endpoint is the percent of

patients who show complete or partial remission   show the rest ...
Followup Visits and Length of Followup Patients will be followed for 24 months after they complete the apheresis procedures.

Study visits will   show the rest ...


New Enrollment PAS for the Liposorber LA-15 System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Reporting Status
six month report 04/10/2014 07/08/2014 Overdue/Received
one year report 10/10/2014    
18 month report 04/10/2015    
two year report 10/10/2015    
three year report 10/09/2016    
four year report 10/09/2017    
five year report 10/09/2018    

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