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RECRUITING
NCT04457154

Pediatric Post-Approval Registry

Sponsor: Inspire Medical Systems, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

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