An Extension Study to Assess the Long-term Safety of the Genio® System
← catalyst calendarNCT05939141 · readout in 1,063 d
Sponsored by Nyxoah S.A. (industry) · NYXH.BR — their whole pipeline →. With Nyxoah Pty. Ltd..
Phase
—
Status
Not yet recruiting
Study type
Observational
Enrollment
39estimated
Sites
7
Country
Australia
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 | Nov 2025 | estimated | When the study began enrolling |
| Primary completion | 2029-07-17 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-07-17 | estimated | The whole study's end, after follow-up |
| First posted | 2023-07-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-04 | 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 of Adult
Intervention
- Device: Genio System
Primary outcome
what the primary-completion date above is the date OFLong-term safety
measured Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"
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