Pediatric Post-Approval Registry

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Inspire Medical Systems, Inc.
Study ID
NCT04457154
Status
Recruiting
Apply to this trial

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Inspire Upper Airway Stimulation System — DEVICE
    Implant of the Inspire Upper Airway Stimulation System

Study Details

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.

Key Dates

Start date
Nov 30, 2021
Status verified
Aug 2024
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Registry Population
    Pediatric subjects (age 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation System for the treatment of moderate to severe obstructive sleep apnea (OSA)

Primary Outcome Measure

Evaluation of device and/or procedure related adverse events over time [ Time Frame: Implant through 5 years post-implant ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Childrens Hospital of ColoradoAuroraColorado80045
Kari Gorecki
[email protected]
Norman Friedman, MD (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of AtlantaAtlantaGeorgia30329-
Duke UniversityDurhamNorth Carolina27705
Donald Luckett
[email protected]
Eileen Raynor, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Childrens HospitalCincinnatiOhio45229
Angie Duggins
[email protected]
David Smith, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19406
Ashley Williams
[email protected]
Lisa Elden, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PittsburghSewickleyPennsylvania15143
Amber Shaffer
[email protected]
Rachel Whelan, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern/Children's Hospital of DallasDallasTexas75207
Francesca Chambers
[email protected]
Ron Mitchell, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of the King's Daughters/East Virginia Medical SchoolNorfolkVirginia23507
Lakshya Enugu
[email protected]
Cristina Baldassari, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Childrens Hospital of Colorado· Aurora, COChildren's Healthcare of Atlanta· Atlanta, GADuke University· Durham, NCCincinnati Childrens Hospital· Cincinnati, OHChildren's Hospital of Philadelphia· Philadelphia, PAChildren's Hospital of Pittsburgh· Sewickley, PA

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