A Post-market Clinical Follow up of the Genio™ System for the Treatment of Obstructive Sleep Apnea in Adults

Last updated: January 10, 2022
Sponsor: Nyxoah S.A.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

N/A

Clinical Study ID

NCT04031040
CL-GEN-002068
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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) orMandibular Advancement Device (MAD) treatments.

Exclusion

Exclusion Criteria:

  • Night shift worker
  • Significant comorbidities that contraindicates surgery
  • Life expectancy < 12 months
  • Participation in another clinical study (excluding registries) during the study period (3 years).

Study Design

Total Participants: 110
Study Start date:
September 01, 2019
Estimated Completion Date:
October 30, 2025

Study Description

This study is a multicenter, prospective single arm PMCF. Following activation of the Genio™ system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.

Connect with a study center

  • Universitair Ziekenhuis Antwerpen

    Antwerp, 2650
    Belgium

    Active - Recruiting

  • Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn

    Antwerp, 2170
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen

    Antwerpen, 2650
    Belgium

    Site Not Available

  • CHU - Angers

    Angers, 49933
    France

    Suspended

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000
    France

    Suspended

  • Hôpital Henri-Mondor AP-HP

    Créteil, 94010
    France

    Suspended

  • Hôpital Privé La Louvière

    Lille, 59800
    France

    Suspended

  • Clinique Beau-Soleil

    Montpellier, 34070
    France

    Suspended

  • CEREVES Paris Jean Jaurès - Centre du sommeil

    Paris, 75019
    France

    Suspended

  • Hôpital Bichat, Assistance Publique - Hôpitaux de Paris

    Paris, 75018
    France

    Suspended

  • Hôpital Tenon AP-HP

    Paris, 75020
    France

    Suspended

  • CHU - Poitiers

    Poitiers, 86021
    France

    Suspended

  • Clinique Mutualiste de la Sagesse

    Rennes, 35000
    France

    Suspended

  • Polyclinique Saint Laurent

    Rennes, 35700
    France

    Suspended

  • CHU Toulouse

    Toulouse, 31400
    France

    Suspended

  • Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie

    Hamburg, 21075
    Germany

    Active - Recruiting

  • HNO-Klinik des Universitätsklinikums Jena

    Jena, 07747
    Germany

    Active - Recruiting

  • Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar der TU München

    München, 81675
    Germany

    Active - Recruiting

  • Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

  • Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

    Wuppertal, 42283
    Germany

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1061 AE
    Netherlands

    Active - Recruiting

  • Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie

    Liestal, 4410
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.