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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 UAS New Enrollment PAS


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General
Study Status Ongoing
Application Number /
Requirement Number
P130008 S089/ PAS001
Date Original Protocol Accepted 05/19/2023
Date Current Protocol Accepted  
Study Name Inspire UAS New Enrollment PAS
Device Name Inspire Upper Airway Stimulation
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Objectives This study is a prospective, multi-center, single-arm study of pediatric subjects (age 13-18) with Down syndrome who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) system for the treatment of severe obstructive sleep apnea (OSA). Subjects will be followed for five (5) years post-implant.
The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.
Study Population Subjects will be recruited in accordance with the approved indications for use and study eligibility criteria which includes:
Inclusion Criteria:
1. Patient has been diagnosed with Down syndrome;
2. Patient is 13-18 years of age;
3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of greater than or equal to 10 and less than or equal to 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);
4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;
5. Patient is contraindicated for, or not effectively treated by adenotonsillectomy;
6. Treatment of patient’s OSA has followed standard of care in considering all other alternative/adjunctive therapies;
7. Patient and their parents/guardians must be willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab PSG sleep studies, and questionnaire completion.
Exclusion Criteria:

8. Patient’s recent PSG (within 6 months of enrollment) reported central + mixed apneas > 25% of the total apnea-hypopnea index (AHI);
9. Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
10. Patient has any condition or procedure that has compromised neurological control of the upper airway;
11. Patient and/or their parent/guardian is unable or does not have the necessary assistance to operate the patient remote;
12. Patient is pregnant or plans to become pregnant;
13. Patient has an implantable device that may be susceptible to unintended interaction with the Inspire System;
14. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;
15. Patient has a terminal illness with life expectancy < 12 months;
16. Any other reason the investigator deems the subject is unfit for participation in the study.
Sample Size Number of subjects: 60
Assumptions for sample size estimation: as recommended by the FDA, A total of sixty (60) subjects, with even distribution across the age range, will be implanted at a minimum of five (5) clinical centers in the United States.
Number of sites: 5
Sites location: US
Key Study Endpoints Safety Endpoints
Primary: Evaluation of device and/or procedure-related adverse events
Secondary: None

Effectiveness Endpoints
Primary:
Evaluation of improvement in Apnea-Hypopnea Index (AHI)
Evaluation of improvement in Oxygen Desaturation Index (ODI)
Evaluation of improvement in T90
Secondary:

Evaluation of improvement in sleepiness symptoms using the ESS-CHAD
Evaluation of Inspire UAS compliance (therapy usage)

Follow-up Visits and Length of Follow-up Subjects will be enrolled in the study prior to implant. Data for each implanted subject will be collected at the following timepoints:

• Baseline
• Implant
• 1 Week Post-op
• Activation (1 Month Post-Implant)
• 2 Months Post-Implant
• 3 Months Post-Implant
• 4 Months Post-Implant
• 6 Months Post-Implant
• 1, 2, 3, 4, 5 Years Post-Implant
• Interim Visits (if applicable)



Inspire UAS New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/18/2023 09/22/2023 Overdue/Received
1 year report 03/19/2024    
18 month report 09/17/2024    
2 year report 03/19/2025    
3 year report 03/19/2026    
4 year report 03/19/2027    
5 year report 03/19/2028    
final report 10/19/2030    


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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