Pediatric Post-Approval Registry
← catalyst calendarNCT04457154 · readout ≤ 499 d
Sponsored by Inspire Medical Systems, Inc. (industry) · INSP — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
60estimated
Sites
8
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-11-30 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2020-07-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-02-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Obstructive Sleep Apnea
Intervention
- Device: Inspire Upper Airway Stimulation System
Primary outcomes
what the primary-completion date above is the date OFEvaluation of device and/or procedure related adverse events over time
measured Implant through 5 years post-implant
Evaluation of the improvement of Apnea Hypopnea Index (AHI) over time
measured through 5 years post-implant
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