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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Open Label PAS of SEDASYS Syst User Resp


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General
Study Status Terminated
Application Number /
Requirement Number		 P080009 / PAS001
Date Original Protocol Accepted 03/29/2013
Date Current Protocol Accepted 03/23/2015
Study Name Open Label PAS of SEDASYS Syst User Resp
Device Name SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study is designed to evaluate the SEDASYS® System can be used safely in routine clinical practice by measuring the trained users responses to System alarms. The intent of this study, as well as the companion study, is to remove the Restriction of Use limiting initial use of the SEDASYS System to settings where an anesthesia provider is immediately available.
Study Population Up to 32 users in up to 15 sites.
Sample Size Accounting for a 3% patient dropout, the resulting sample size will be 866.
Key Study Endpoints The primary endpoint will be the percentage of documented responses to alarms.
The secondary endpoint will be the sufficiency of response, which is measured by a score for success.
Other Safety Endpoints:
Adverse events (defined by MeDRA) and all hands-on airway rescue interventions by anesthesia providers will be reported. Stopping Rules:
The study may be stopped by the Sponsor in the event of a single confirmed non-response to an alarm (desaturation, apnea, hypotension, bradycardia). Confirmation of a non- response will be determined by the EAC; assessment will include if the Data Acquisition System (DAQ) failed to record a response. The reason for failure to respond will be assessed by EES and continuance of the study will be based on this assessment. The expected rate of DAQ failure is approximately one percent. Confirmed non-responses will be sent to the Agency within 15 days of the EAC notifying the Sponsor.
Follow-up Visits and Length of Follow-up Duration of each subject's participation is approximately 2 days (one day participation and one day follow up).
Interim or Final Data Summary
Actual Number of Patients Enrolled 51
Actual Number of Sites Enrolled 1
Patient Follow-up Rate n/a
Final Safety Findings n/a
Final Effect Findings n/a
Study Strengths & Weaknesses n/a
Recommendations for Labeling Changes no


Open Label PAS of SEDASYS Syst User Resp Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 11/01/2013 12/16/2013 Overdue/Received
one year report 05/03/2014 05/02/2014 On Time
18 month report 11/01/2014 10/30/2014 On Time
two year report 05/03/2015 04/23/2015 On Time
Final Report 06/03/2016 05/03/2016 On Time


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

Additional Resources

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