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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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Inspire Pediatric Post-Approval Registry


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General
Study Status Delayed
Application Number /
Requirement Number		 P130008 S039/ PAS001
Date Original Protocol Accepted 06/12/2020
Date Current Protocol Accepted 12/16/2022
Study Name Inspire Pediatric Post-Approval Registry
Device Name Inspire Upper Airway Stimulation
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives The objective of the registry is to collect safety and effectiveness data related to the new age indication, in a postmarket
setting.
Study Population Subjects will be recruited in accordance with the approved indication for use and will only include those subjects who are
within the new age indication (18-21 years). Subjects will be considered enrolled at the time of informed consent.
Implanted subjects must meet the registry eligibility criteria and will be followed for 5 years post implant. Those subjects
that are enrolled but fail to meet the eligibility criteria will be considered screen failures.
Sample Size This registry will collect safety and effectiveness data on 60 implanted subjects at minimum of 5 qualified centers in the
United States.
Key Study Endpoints An evaluation of safety will include the following:
Evaluation of device and/or procedure related adverse events over time:
relevant adverse events will be collected and reported through 5 years postimplant. An evaluation of effectiveness will include the following:
Evaluation of improvement in Apnea Hypopnea Index (AHI) over time:
baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits)
Evaluation of improvement in Oxygen Desaturation Index (ODI) over time:
baseline (pre-implant) ODI compared to ODI after implant (collected and reported at annual study visits)
Evaluation of improvement in T90 (defined as total sleep time spent with arterial oxygen saturation (SaO2) < 90%) over time:
baseline (pre-implant) T90 compared to T90 after implant (collected and reported at annual study visits)
Evaluation of improvement of Epworth Sleepiness Scale (ESS) over time:
baseline (pre-implant) ESS compared to ESS after implant (collected and reported at annual study visits
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 5
Actual Number of Sites Enrolled 7
Patient Follow-up Rate N/A
Final Safety Findings N/A
Final Effect Findings N/A


Inspire Pediatric Post-Approval Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/13/2020 11/17/2020 Overdue/Received
1 year report 04/14/2021 04/26/2021 Overdue/Received
18 month report 10/13/2021 10/15/2021 Overdue/Received
2 year report 04/14/2022 04/21/2022 Overdue/Received
30 month report 10/14/2022 10/17/2022 Overdue/Received
3 year report 04/14/2023 04/14/2023 On Time
42 month report 10/14/2023 10/12/2023 On Time
4 year report 04/14/2024 04/11/2024 On Time
51 month report 07/14/2024 07/16/2024 Overdue/Received
5 year report 04/13/2025    


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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