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A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
Sponsor: Nyxoah S.A.
Summary
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
Official title: A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2019-09-01
Completion Date
2030-10
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
Genio® system therapy
Hypoglossal nerve stimulation system
Locations (19)
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
Antwerp, Belgium
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
CHU - Angers
Angers, France
Hôpital Henri-Mondor AP-HP
Créteil, France
Hôpital Privé La Louvière
Lille, France
Clinique Beau-Soleil
Montpellier, France
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
Paris, France
CEREVES Paris Jean Jaurès - Centre du sommeil
Paris, France
Hôpital Tenon AP-HP
Paris, France
Clinique Mutualiste de la Sagesse
Rennes, France
Polyclinique Saint Laurent
Rennes, France
CHU Toulouse
Toulouse, France
Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie
Hamburg, Germany
HNO-Klinik des Universitätsklinikums Jena
Jena, Germany
Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum
Mannheim, Germany
Klinikum rechts der Isar der TU München
München, Germany
Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
Wuppertal, Germany
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie
Liestal, Switzerland