What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are F&P Licorice Mask. The registry lists allocation as na. This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.
They plan to enroll about 45 people at St Louis. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Evaluation of the F&P PAP Mask, US, 2026
Interventions: F&P Licorice Mask
Primary outcome (registry wording): Therapeutic Efficacy