An Extension Study to Assess the Long-term Safety of the Genio® System
- Conditions
- Obstructive Sleep Apnea of Adult
- Interventions
- Device: Genio System
- Registration Number
- NCT05939141
- Lead Sponsor
- Nyxoah S.A.
- Brief Summary
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.
- Detailed Description
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.
All subjects that have previously participated in a Nyxoah sponsored clinical investigation in Australia, and who are currently still implanted with an implantable stimulator (with therapy activated or de-activated) will be asked to participate in this long-term safety follow-up study and will be asked to report any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 39
- 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).
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OLE Subjects Genio System 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 and having the device in-situ at the time of enrollment (with therapy activated or de-activated).
- Primary Outcome Measures
Name Time Method Long-term safety Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years" Long term safety of the Genio System as measured by the rate and type of Adverse Device Effects, Serious Adverse device Effects and Device Deficiencies overtime in subjects in Australia previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
The Woolcock Institute Of Medical Research
🇦🇺Sydney, New South Wales, Australia
Westmead Public Hospital
🇦🇺Sydney, New South Wales, Australia
Illawarra ENT and Head & Neck Clinic
🇦🇺Sydney, New South Wales, Australia
Complete ENT
🇦🇺Brisbane, Queensland, Australia
Monash Health - Department of Respiratory and Sleep Medicine
🇦🇺Melbourne, Victoria, Australia
Institute for Breathing and Sleep (IBAS)
🇦🇺Melbourne, Victoria, Australia
Perth Head & Neck Surgery
🇦🇺Perth, Western Australia, Australia