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Pediatric Post-Approval Registry
Sponsor: Inspire Medical Systems, Inc.
Summary
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
Official title: Inspire Pediatric Post-Approval Registry
Key Details
Gender
All
Age Range
18 Years - 21 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2021-11-30
Completion Date
2028-04
Last Updated
2025-02-25
Healthy Volunteers
No
Conditions
Interventions
Inspire Upper Airway Stimulation System
Implant of the Inspire Upper Airway Stimulation System
Locations (8)
Childrens Hospital of Colorado
Aurora, Colorado, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Duke University
Durham, North Carolina, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Sewickley, Pennsylvania, United States
University of Texas Southwestern/Children's Hospital of Dallas
Dallas, Texas, United States
Children's Hospital of the King's Daughters/East Virginia Medical School
Norfolk, Virginia, United States