An Extension Study to Assess the Long-term Safety of the Genio® System
ConditionObstructive Sleep Apnea of Adult
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNyxoah S.A.
About this trial
The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation.
(Serious) Adverse Device Effects and Device Deficiencies in subjects previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated) will be collected.
The main question it aims to answer is: what is the long term safety profile of the Genio System?
Participants will be asked to refer back to the site per standard of care and report on any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.
Eligibility criteria
Qualifiers
Subject voluntarily signed an Informed Consent Form
Subject is currently implanted with a Genio® Implantable Stimulator (IS), with therapy active or inactive, and was included in and subsequently exited a Nyxoah sponsored clinical investigation (either by study completion or withdrawal). These studies include, but are not limited to BLAST OSA (CL-GEN-001203), BETTER SLEEP (CL-GEN-001908), DREAM (CL-GEN-002033) or, subject is currently implanted with a Genio® Implantable Stimulator (IS) and accessing therapy via the TGA special access scheme (SAS).
Disqualifiers
None
Trial design
Treatments tested in this trial
- Genio System
Treatment groups
39 Participants
are divided into 1 treatment groupSponsors and collaborators
Nyxoah S.A.
Lead sponsor
Nyxoah Pty. Ltd.
Collaborator
Source ClinicalTrials.gov