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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Extended F/U-Barricaid ACD Premarket Cohort


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General
Study Status Study Pending
Application Number P160050 / PAS001
Date Current Protocol Accepted  
Study Name Extended F/U-Barricaid ACD Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this post-approval clinical study is to examine the long-term survivorship of the Barricaid® ACD when used in conjunction with limited

discectomy. This study is also intended to monitor the natural history of endplate lesions due to interactions with the device, potential interactions with the development of osteoporosis, lesion growth and lesion stability. The study is also intended to investigate potential underlying mechanisms that may contribute to any additional growth through retrieval analysis and histological analysis of periprosthetic tissue.

Extended Follow-up From a 2-Year RCT
Study Population Description Extended follow-up of RCT Subjects – investigational (Barricaid + Discectomy) vs control (Discectomy Alone)
Sample Size This study is not powered to demonstrate statistical conclusions, but rather the sample size is based on the subjects from the original 2-year study who agree to participate in longer-term follow-up.
Data Collection Secondary Surgical Intervention (SSI), SAEs, AEs, Device Failures, Radiographic Observations, Symptomatic Reherniations, All Reherniations

VAS, ODI will all be collected.
Follow-up Visits and Length of Follow-up 10 years, with potentially additional 3 year increments.


Extended F/U-Barricaid ACD Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/09/2019   Overdue
one year report 02/08/2020    
18 month report 08/08/2020    
two year report 02/07/2021    
three year report 02/07/2022    
four year report 02/07/2023    
five year report 02/07/2024    
six year report 02/06/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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