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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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Cont F/u (OPSPREY Study)


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General
Study Status Ongoing
Application Number /
Requirement Number		 P250013 / PAS001
Date Original Protocol Accepted 06/18/2026
Date Current Protocol Accepted 06/18/2026
Study Name Cont F/u (OPSPREY Study)
Device Name aura6000™ system
Clinical Trial Number(s) NCT04950894 
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives A multi-center prospective, observational, open label, long-term follow-up of the Aura6000® System in patients who have completed the OSPREY clinical trial. OSPREY subjects will be evaluated for adverse events and will also undergo HSTs annually and/or PSG as well as an impedance check to assess IPG function twice a year.
The purpose of this study is to quantify long-term efficacy and safety outcomes in subjects who have participated in the OSPREY clinical trial and have completed the M13 visit.
Study Population All subjects participating in the OSPREY clinical trial who have completed M13 of the OSPREY study will be offered participation to this study.
Sample Size Number of subjects: 150
Assumptions for sample size estimation: As a descriptive study there is no formal hypothesis, and a formal sample size calculation is not necessary.
Number of sites: 30
Sites location: US
Key Study Endpoints Primary: Descriptive evaluation of all reported Adverse events.
Secondary: N/A

Effectiveness Endpoints
Primary: The primary endpoint is to evaluate change in AHI (Apnea Hypopnea Index) relative to the pre-therapeutic baseline in subjects implanted with Aura6000® System annually based on HST and/or PSG data.
Secondary: The change in ODI, ESS and FOSQ between pre-therapeutic timepoint and annual visit. Clinical Global Impression S (CGI S) at pre-therapeutic timepoint and Clinical Global Impression I (CGI I) annually thereafter.
Follow-up Visits and Length of Follow-up Enrollment is expected to be 24 months with follow up to additional 48 months. The M48 will equate to approximately 60 months (5 years) on therapy for subjects randomized to the active group and approximately 54 months (4.5 years) for subjects randomized to the control group.


Cont F/u (OPSPREY Study) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/16/2026    
1 year report 03/18/2027    
2 year report 03/17/2028    
3 year report 03/17/2029    
4 year report 03/17/2030    


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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