Clinical Research Directory
Browse clinical research sites, groups, and studies.
An Extension Study to Assess the Long-term Safety of the Genio® System
Sponsor: Nyxoah S.A.
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.
Official title: A Prospective, Open-label, Multicentric Extension Study to Assess the Long-term Safety of the Genio® System in Study Subjects Who Have Been Implanted With the Genio® Implantable Stimulator (IS) for the Treatment of OSA in Adult Patients.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
39
Start Date
2025-11
Completion Date
2029-07-17
Last Updated
2025-06-04
Healthy Volunteers
Yes
Conditions
Interventions
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.
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
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