A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults.
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Body Mass Index (BMI) \< 35 kg/m2
• AHI between 15 to 65 events/hour documented by a PSG during the screening phase.
• Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.
Locations
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen
RECRUITING
Antwerp
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
RECRUITING
Antwerp
France
CHU - Angers
SUSPENDED
Angers
Centre Hospitalier Intercommunal de Créteil
SUSPENDED
Créteil
Hôpital Henri-Mondor AP-HP
SUSPENDED
Créteil
Hôpital Privé La Louvière
SUSPENDED
Lille
Clinique Beau-Soleil
SUSPENDED
Montpellier
CEREVES Paris Jean Jaurès - Centre du sommeil
SUSPENDED
Paris
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
SUSPENDED
Paris
Hôpital Tenon AP-HP
SUSPENDED
Paris
CHU - Poitiers
SUSPENDED
Poitiers
Clinique Mutualiste de la Sagesse
SUSPENDED
Rennes
Polyclinique Saint Laurent
SUSPENDED
Rennes
CHU Toulouse
SUSPENDED
Toulouse
Germany
Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie
RECRUITING
Hamburg
HNO-Klinik des Universitätsklinikums Jena
RECRUITING
Jena
Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum
RECRUITING
Mannheim
Klinikum rechts der Isar der TU München
RECRUITING
München
Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg
NOT_YET_RECRUITING
Regensburg
Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
ACTIVE_NOT_RECRUITING
Wuppertal
Netherlands
Onze Lieve Vrouwe Gasthuis
RECRUITING
Amsterdam
Switzerland
Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie
RECRUITING
Liestal
Contact Information
Primary
Jey Subbaroyan, PhD
Jey.Subbaroyan@Nyxoah.com
+1 (734) 277-3273
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 110
Treatments
Experimental: Genio(TM) system therapy
Following activation of the Genio™ system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery.
Authors
Related Therapeutic Areas
Sponsors
Leads: Nyxoah S.A.