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

This trial accepts healthy volunteers

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 population

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 in Australia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Genio System
Device
All participants have previously been implanted with a Genio® system implantable stimulator. This research is observational in nature (long term safety follow-up) and participants will not be exposed to additional procedures. The Genio System comprises of a bilateral Implantable Stimulator (IS), which is implanted via a minimally invasive surgery procedure and positioned over the genioglossus muscle with its electrodes positioned over both the left and right hypoglossal nerve branches. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway. The Implantable Stimulator receives energy pulses transmitted via the DP placed under the patient's chin and connected to the Activation Chip (AC), which contains the patient's stimulation parameters and contain a battery that provides energy.

Treatment groups

39 Participants

are divided into 1 treatment group

Group A: OLE Subjects1 intervention

Trial outcomes

Primary outcomes

Long-term safety

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).

Time frame

Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nyxoah S.A.

Lead sponsor

Nyxoah Pty. Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: