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Pediatric Post-Approval Registry

NCT04457154 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Inspire Upper Airway Stimulation System

Implant of the Inspire Upper Airway Stimulation System

Sponsors & Collaborators

  • Inspire Medical Systems, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2027-12-31
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04457154 on ClinicalTrials.gov