An Extension Study to Assess the Long-term Safety of the Genio® System
NCT ID: NCT05939141
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
39 participants
OBSERVATIONAL
2025-11-30
2029-07-17
Brief Summary
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(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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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OLE Subjects
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).
Genio System
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.
Interventions
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Genio System
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
ALL
Yes
Sponsors
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Nyxoah Pty. Ltd.
INDUSTRY
Nyxoah S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Lewis, MBBS
Role: PRINCIPAL_INVESTIGATOR
Perth Head & Neck Surgery
Locations
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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
Institute for Breathing and Sleep (IBAS)
Melbourne, Victoria, Australia
Monash Health - Department of Respiratory and Sleep Medicine
Melbourne, Victoria, Australia
Perth Head & Neck Surgery
Perth, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Ronald Grunstein
Role: primary
John Wheatley, MBBS
Role: primary
Stuart MacKay, MBBS
Role: primary
Leon Kitipornchai, MBBS
Role: primary
Maree Barnes, MBBS
Role: primary
Darren Mansfield
Role: primary
Richard Lewis, MBBS
Role: primary
Other Identifiers
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CL-OLE2023
Identifier Type: -
Identifier Source: org_study_id
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