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The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genio(TM) system therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genio(TM) bilateral hypoglossal nerve stimulation system | Device | Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Incidence of serious device-related adverse events) | Incidence of serious device-related adverse events | 6-months post implantation |
| Performance | Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI) | 6-months post implantation |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie Attali, Dr. | La Pitié Salpêtrière, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hollywood Private UWA Centre for Sleep Science Facility | Nedlands | Perth | Australia | |||
| La Pitié Salpêtrière - Paris |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31601716 | Derived | Eastwood PR, Barnes M, MacKay SG, Wheatley JR, Hillman DR, Nguyen XL, Lewis R, Campbell MC, Petelle B, Walsh JH, Jones AC, Palme CE, Bizon A, Meslier N, Bertolus C, Maddison KJ, Laccourreye L, Raux G, Denoncin K, Attali V, Gagnadoux F, Launois SH. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020 Jan 9;55(1):1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan. |
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|
| Paris |
| France |
| Royal National Throat, Nose and Ear Hospital - London | London | United Kingdom |