f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

Inspire UAS High AHI/High BMI PAS


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Ongoing
Application Number /
Requirement Number
P130008 S090/ PAS001
Date Original Protocol Accepted 08/04/2023
Date Current Protocol Accepted  
Study Name Inspire UAS High AHI/High BMI PAS
Device Name Inspire Upper Airway Stimulation System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own 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 a prospective, multi-center, two-arm study of subjects with an Apnea-Hypopnea Index (AHI) > 65 and <= 100 events/hr and/or Body Mass Index (BMI) >32 and <= 40 kg/m2, who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of obstructive sleep apnea (OSA). Subjects will be followed for 5 years post-implant
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 AHI (65 < AHI <=100 events/hr) and BMI (32 < BMI<=40 kg/m2) ranges. Subjects will be considered enrolled at the time of informed consent. Implanted subjects must meet the study 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.

Study arms:
AHI Cohort: Includes subjects with 65 < AHI<=100 events/hr
BMI Cohort: Includes subjects with 32 < BMI<=40 kg/m2
Sample Size Number of subjects: 70 implanted subjects - 35 implanted subjects in each arm
Assumptions for sample size estimation: NA
Number of sites: 5
Sites location: US
Key Study Endpoints Safety Endpoints
Primary: Evaluation of device and/or procedure related adverse events over time: relevant adverse events will be collected and reported through 5 years post-implant
Secondary: NA

Effectiveness Endpoints
Primary:
• 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)

Subjects enrolled in the BMI cohort will have their BMI monitored yearly throughout the study
Secondary: NA
Follow-up Visits and Length of Follow-up • Baseline
• Implant
• Activation (1 Month Post-Implant)
• 6 Months Post-implant
• 1, 2, 3, 4, 5 Years Post-Implant


Inspire UAS High AHI/High BMI PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/07/2023 12/04/2023 On Time
1 year report 06/07/2024    
18 month report 12/06/2024    
2 year report 06/07/2025    
3 year report 06/07/2026    


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

-
-